Traumatic Brain InjuryNCT06817564
AI-driven Personalized Exercise Feedback Program on Exercise Adherence in Traumatic Brain Injury
A study testing AI-PEF and Theory-based digital exercise in people with Traumatic Brain Injury and Exercise, run by National Defense Medical Center, Taiwan.
Trial summary
This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance exercise adherence and health outcomes in mTBI patients. Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Exercise, AI (Artificial Intelligence)
- What is being tested?
- AI-PEF and Theory-based digital exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2026to 31 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants are patients aged over 18 with mild TBI (GCS 13-15)
- who can walk independently,
- reside in the Greater Taipei area,
- and possess sufficient Chinese or Taiwanese language proficiency to understand the trial
- complete self-administered questionnaires.
Who cannot join
- include individuals with severe medical conditions (e.g., respiratory failure, epilepsy, psychiatric disorders), musculoskeletal or neurological impairments
- hindering physical activity in the 6-minute walk test,
- cognitive impairments (MMSE < 24),
- frontal lobe injuries or penetrating injury causing significant psychological dysfunction.
- Patients regularly engaging in moderate-to-high-intensity aerobic exercise or participating in other studies will also be excluded to avoid bias.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of an AI-driven Personalized Exercise Feedback Program on Exercise Adherence and Health Outcomes in Patients With Traumatic Brain Injury
This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance exercise adherence and health outcomes in mTBI patients.
Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I evaluates feasibility and acceptability through Delphi methods with expert consensus and patient feedback; Phase II validates preliminary outcomes with 30 participants in a 2-arm randomized trial; and Phase III assesses the program's impact on exercise adherence, exercise motivation, mHealth app usability, functional capacity, sleep quality, depressive symptoms, concussion symptoms, and quality of life with 90 participants in a 3-arm randomized trial. In Phase III, quantitative and qualitative data will be collected in parallel, with qualitative data collected through semi-structured interviews to explore participants' experiences and perceptions of the intervention.
Read the detailed description
The study will employ a stepwise, multi-phase design, combining a two- parallel-group pilot study and a three-arm randomized controlled trial (RCT) to evaluate the appropriateness, feasibility, acceptability, and effectiveness of the AI-PEF (Figure 5). Participants will be recruited from the neurosurgery clinics at Tri-Service General Hospital, Taipei. Recruitment will be facilitated through referrals by attending physicians and registered nurses, who will be briefed on the study protocol.
Study procedures
- Phase I (Year 1): Development and Pilot Testing (Aim 1) Phase I will focus on developing and refining the AI-PEF through expert validation and pilot testing. This phase will use a sequential-parallel hybrid design to develop and evaluate the appropriateness of the AI-PEF to deliver personalized exercise empowerment. Stage 1, Delphi Process for AI-PEF Development: Ten experts from diverse fields will participate in two Delphi rounds to finalize the AI-PEF framework. This includes refining algorithms, educational materials, and preliminary validation of key components, such as personalization algorithms and behavior-change strategies. Stage 2, Small-Scale Pilot Study (Early Feedback): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.
- Phase II : Larger Pilot Study (Aim 2) Phase II will focus on evaluating the feasibility, acceptability, and preliminary effectiveness of the refined AI-PEF intervention. A two-parallel-group design will be employed, with 30 participants, 15 participants per group, randomly assigned in a 1:1 ratio to the AI-PEF group and Active control group. Over three months, AI-PEF participants will engage in personalized exercise guided by AI, while active control participants will follow standard exercise recommendations. Both qualitative and quantitative data will be collected. Assessments will occur at baseline (T0) and 3 months (T1), including fitness tracker data, questionnaires (motivation, sleep, symptoms), and semi-structured interviews. The primary outcome of interest will be adherence rates, while secondary outcomes will focus on motivation and various health metrics.
- Phase III : Full- scale three-arm RCT (Aim 3) Phase III will assess the long-term impact of the AI-PEF on exercise adherence, motivation, and health outcomes through a 3-arm RCT, in which participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) the AI-PEF group, receiving a machine learning-powered personalized exercise program; (2) the Theory-based digital exercise group, engaging in structured digital exercise without machine learning-powered feedback; or (3) the Active control group, receiving general exercise recommendations as part of standard care. Participants will receive group-specific interventions during the 12-week intervention period and will be followed for six months, with assessments conducted at baseline (T1), 1 month (T2), 2 months (T3), 3 months (T4), and the 6-month follow-up (T5).
Primary outcomes will include exercise adherence, exercise motivation, mHealth app usability, and functional capacity. Exercise adherence will be objectively measured via Garmin fitness trackers; exercise motivation and mHealth app usability will be assessed through standardized questionnaires; and functional capacity will be evaluated using the 6-Minute Walk Test. Secondary outcomes, such as sleep quality, depressive symptoms, concussion symptoms, and quality of life, will also be assessed through standardized questionnaires. These standardized questionnaires are being used in our current digital remote exercise trial in patients with mild TBI (NSTC 112-2314-B-016-007-MY2) and have demonstrated good psychometric performance.
Quantitative and qualitative data will be collected and analyzed in parallel.Quantitative data will be used to compare adherence, motivation, usability, functional capacity, and health outcomes across the three groups and to evaluate the efficacy of AI-PEF relative to standard interventions. Qualitative interviews will explore participants' experiences and perceptions of the intervention. Procedures will adhere to the blinding and randomization protocols described in Intervention Fidelity, ensuring unbiased assignment and data collection processes. This proposed study protocol is closely aligned with those that have been successfully implemented in our previous digital exercise trial.
- Being tested
- AI-PEF, Theory-based digital exercise, Active Control
- Keywords
- AI-Driven Personalized Exercise Program
- Medical subject headings
- Brain Injuries, Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-PEFBehavioural
Participants will follow a 12-week walking program with at least three 30-minute sessions per week, with exercise intensity progressively adjusted based on heart rate and effort indices. Garmin fitness trackers will monitor exercise adherence and intensity. Remote guidance will be provided through five AI-generated digital health messages per week via LINE, delivered on Monday, Tuesday, Thursday, Friday, and Saturday, and tailored to participants' exercise performance and individualized goals established during the remote exercise intervention and consultation. The messages will include exercise performance feedback, goal setting and reinforcement, exercise and device-use reminders, health education, and encouragement and support. The digital component will allow participants to share their progress and seek guidance during scheduled in-person consultations. AI-driven digital feedback provides a convenient and accessible approach to supporting participants in engaging in exercise.
Theory-based digital exerciseBehavioural
The theory-based digital exercise group will follow the same in-person clinic visits, assessment schedule, and 12-week walking program as the AI-PEF group. Garmin fitness trackers will be used to monitor exercise adherence and intensity. The research team will deliver five standardized digital health messages per week through the LINE app using message templates developed in advance. The messages will include exercise guidance, goal setting and reinforcement, exercise and device-use reminders, health education and lifestyle recommendations, and encouragement and support. The messages will not be generated or tailored by AI, and participants will not receive AI-driven personalized feedback.
Active ControlBehavioural
Participants in the active control group will receive standard TBI care, including routine clinic visits. In addition, Garmin fitness trackers will be provided for self-monitoring during the study. The research team will deliver five standardized general health messages per week through the LINE app. The messages will include TBI-related health education, general health and lifestyle information, general recommendations for daily physical activity, general check-in messages, and technical reminders for Garmin use. The messages will not include structured exercise guidance, individualized goal setting or reinforcement, performance-based feedback, or AI-generated personalized feedback. Participants completing the 6-month protocol will have the option to access the AI-PEF program after the study.
| Study group | Role | What they receive |
|---|---|---|
| AI-PEF | Experimental | the AI-PEF group, receiving a machine learning-powered personalized exercise program. Receives: Behavioral: AI-PEF |
| Theory-based digital exercise | Experimental | Theory-based digital exercise group, engaging in structured digital exercise without machine learning- powered feedback. Receives: Behavioral: Theory-based digital exercise |
| Active control group | Active comparator | the Active control group, receiving general exercise recommendations as part of standard care in a 1:1:1 ratio. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T1-baseline
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T2- 1 month later
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T3- 2 month later
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T4- 3 month later
Adherence
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Measured: T5- 6 month later
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T1- baseline
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T2- 1 month later
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T3- 2 month later
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T4- 3 month later
The Chinese Version of the Sport Motivation Scale-II
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
Measured: T5- 6 month later
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T1- baseline
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T2- 1 month later
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T3- 2 month later
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T4- 3 month later
The mHealth App usability questionnaire
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
Measured: T5- 6 month later
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
Measured: T1- baseline
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
Measured: T2- 1 month later
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
Measured: T3- 2 month later
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
Measured: T4- 3 month later
6-Minute Walk Test
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
Measured: T5- 6 month later
Secondary outcomes (55)
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms.
Measured: T1- baseline
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms.
Measured: T2- 1 month later
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms.
Measured: T3- 2 month later
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms.
Measured: T4- 3 month later
The Rivermead Post-Concussion Symptoms Questionnaire
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) will assess physical, cognitive, and behavioral symptoms associated with TBI, validated for mild to moderate TBI cases. A total of 16 items, scored 0-4, ranged 0- 64, the higher scores mean the severity of the concussion symptoms.
Measured: T5- 6 month
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T1- baseline
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T2-1 month later
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T3- 2 month later
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T4-3 month later
The Beck Depression Inventory-II
The Beck Depression Inventory-II (BDI-II), with total scores categorized as follows: 0-13 (normal), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression), will evaluate depressive symptoms with established reliability (α = 0.94) and validity.
Measured: T5- 6 month later
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: T1-baseline
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version [68]. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
Measured: T2- 1 month later
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version [68]. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
Measured: T3-2 month later
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version [68]. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
Measured: T4-3 month later
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, using a validated Chinese version [68]. Previous research has demonstrated good internal consistency reliability (0.82) and 14- to 21-day test-retest reliability (0.85) of the PSQI Chinese version in Taiwan's populations. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
Measured: T5-6 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T1 -baseline
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active .
Measured: T2 -1 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T3 -2 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T4-3 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
The Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPA) will measure weekly physical activity intensity, classified into light, moderate, and vigorous levels. The Chinese version of the GLTPA has shown good validity and is significantly correlated with mental health outcomes. By classifying physical activity intensity lasting for more than 15 minutes in the past week into strenuous activities, moderate strenuous activities, and light activities, and then multiplying by corresponding coefficients 9, 5, and 3 respectively for quantification, the sum of these scores is Godin's leisure time physical Total activity score, with higher scores indicating greater physical activity. The level of physical activity can be divided into three levels according to the total Godin leisure time physical activity score. A total score of 24 or above is considered active, a score between 14 and 23 is moderately active, and a score below 14 is consider Insufficiently active.
Measured: T5-6 month later
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T1 - baseline
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T2 - 1 month later
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T3 - 2 month later
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T4 - 3 month later
The World Health Organization Quality of Life Scale-brief
The World Health Organization Quality of Life Scale-brief (WHOQOL-BREF), validated in Chinese, with good internal consistency (α = 0.70-0.77), overall reliability (α = 0.91), and test-retest reliability (0.76-0.80), will assess the quality of life across four domains: physical, psychological, social, and environmental well-being. This scale covers subjective life feelings in four major categories: physical health, psychological, social relations, and environment. It has 24 questions in total. There are also 2 questions measuring the overall quality of life and general health at the general level. (general health), in addition, the Taiwan version adds 2 local questions, namely diet (whether you can eat the food you want) and face issues (whether you are respected), a total of 28 questions, and the scores for each category are introduced. Between 4 and 20, the higher the score, the better the quality of life.
Measured: T5- 6 month later
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T1- baseline
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds [75]. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury [76]. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T2-1 month later
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds [75]. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury [76]. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T3-2 month later
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T4-3 month later
Mini-Mental State Examination
Cognitive function will be assessed pre-enrollment using the MMSE, with validated age- and education-adjusted thresholds. The MMSE has demonstrated good reliability and validity and is a strong predictor of disability levels in patients with traumatic brain injury. Participants with an MMSE score below 24 will be excluded from the study to ensure appropriate cognitive capacity for participation. The score range is 0-30 points, with the international standard cut-off value of 24 points, 18-24 points as mild dementia, 16-17 points as moderate dementia, and ≦15 points as severe dementia.
Measured: T5- 6 month later
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T1-baseline
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T2-1 month later
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T3-2 month later
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T4-3 month later
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a sensitive tool for the early screening of mild cognitive impairment, particularly useful for detecting deficits in executive function, attention, short-term memory, language fluency, abstract thinking, and visuospatial abilities. The total score of the scale is 30 points, with a score of less than 26 considered indicative of possible mild cognitive impairment. The score can be adjusted (+1 point) based on educational level. The Chinese version of MoCA has been proven to have good reliability and validity (Cronbach's α = 0.83) and is particularly suitable for research populations in Asian regions.
Measured: T5-6 month later
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T1 - baseline
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T2- 1 month later
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T3-2 month later
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T4- 3 month later
Near-Infrared Brain Blood Flow Imaging
In this study, the Biolight MediTECH® near-infrared brain blood flow imaging sensor (hemoencephalography; HEG) was used to measure blood flow in the prefrontal cortex. The Biolight near-infrared spectroscopy device is an HEG sensor designed by MediTECH®, based on NIR technology to observe the optical properties of cells and tissues at the reflection level. This enables monitoring of changes in oxyhemoglobin and deoxyhemoglobin concentrations. By measuring light absorption at different wavelengths, the system can continuously track changes during tissue oxidation processes, thereby measuring cerebral blood flow conditions. The percentage of the NIR brain blood flow ranged 0- 100%, the higher percentage means the higher prefrontal brain blood flow.
Measured: T5- 6 month later
cardiac metabolic performance benchmark
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise. The benchmark will be calculated by the Heart rate measured by Garmin fitness bracelet.
Measured: T1- baseline
cardiac metabolic performance benchmark
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise.
Measured: T2- 1 month later
cardiac metabolic performance benchmark
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise.
Measured: T3-2 month later
cardiac metabolic performance benchmark
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise.
Measured: T4- 3 month later
cardiac metabolic performance benchmark
Preliminary findings from this study applied the cardiac metabolic performance benchmark (CMPB3) to compare the effectiveness of increasing cerebral blood circulation at different intensities (CMPB3 ≤ 35, 40, 45, 50). Results indicated that CMPB3 levels above 40 effectively increased cerebral blood circulation, with improvements observed not only during exercise but also during the post-exercise rest period, where cerebral blood flow remained higher than the baseline level. The lower intensity means the lower exercise intensity and the higher ability to perform aerobic walking exercise.
Measured: T5- 6 month later
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data.
It is a qualitative data, not a quantitative data.
The interview content covers three major themes:
- Benefits of the walking program;
- Experiences and challenges of the walking program;
- The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T1- baseline
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data.
It is a qualitative data, not a quantitative data.
The interview content covers three major themes:
- Benefits of the walking program;
- Experiences and challenges of the walking program;
- The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T2- 1 month later
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data.
It is a qualitative data, not a quantitative data.
The interview content covers three major themes:
- Benefits of the walking program;
- Experiences and challenges of the walking program;
- The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T3- 2 month later
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data.
It is a qualitative data, not a quantitative data.
The interview content covers three major themes:
- Benefits of the walking program;
- Experiences and challenges of the walking program;
- The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T4-3 month later
Semi-Structured Interviews
This study will adopt semi-structured interviews to gain an in-depth understanding of participants' experiences and perceptions of the walking program, as well as to complement and interpret quantitative data.
It is a qualitative data, not a quantitative data.
The interview content covers three major themes:
- Benefits of the walking program;
- Experiences and challenges of the walking program;
- The impact of the walking program on quality of life, sleep quality, concussion symptoms, psychological resilience, depression, exercise motivation, exercise self-efficacy, and physical activity.
Measured: T5- 6 month later
Physiological Monitoring Tools
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
Measured: T1- baseline
Physiological Monitoring Tools
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
Measured: T2- 1 month later
Physiological Monitoring Tools
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
Measured: T3-2 month later
Physiological Monitoring Tools
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
Measured: T4-3 month later
Physiological Monitoring Tools
Garmin Vivosmart 5. This wearable device will track heart rate, exercise frequency, exercise duration, exercise intensity, step count, and sleep data. Data will be integrated with the Garmin Connect app for real-time monitoring and feedback. A preliminary study conducted by our research team in 2020 showed a high correlation (r = 0.91) between heart rate measurements obtained from the Garmin Vivosmart and the Zephyr BioHarness, supporting its use for home-based heart rate monitoring. Participants will wear the device at home to facilitate real-time tracking of exercise intensity and physiological responses during the intervention. Advanced sleep tracking in compatible Garmin devices incorporates multiple factors to provide information on sleep patterns. In addition to basic information, such as sleep onset and wake-up time, researchers will be able to obtain data on periods of wakefulness and time spent in key sleep stages, including light, deep, and rapid eye movement (REM) sleep.
Measured: T5- 6 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start17 Aug 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2: Evaluate the feasibility, acceptability, and preliminary effectiveness of the AI-PEF in improving patient outcomes. Phase 3: Examine the impact of the AI-PEF on exercise adherence and health outcomes
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Hsun Chiang, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817564
- Sponsor's protocol ID
- AI feedback digital exercise
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an AI-driven Personalized Exercise Feedback Program on Exercise Adherence and Health Outcomes in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06817564
- Acronym / sponsor ID
- AI feedback digital exercise
- Keywords
- AI-Driven Personalized Exercise Program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance exercise adherence and health outcomes in mTBI patients.
Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I evaluates feasibility and acceptability through Delphi methods with expert consensus and patient feedback; Phase II validates preliminary outcomes with 30 participants in a 2-arm randomized trial; and Phase III assesses the program's impact on exercise adherence, exercise motivation, mHealth app usability, functional capacity, sleep quality, depressive symptoms, concussion symptoms, and quality of life with 90 participants in a 3-arm randomized trial. In Phase III, quantitative and qualitative data will be collected in parallel, with qualitative data collected through semi-structured interviews to explore participants' experiences and perceptions of the intervention.
Detailed description
The study will employ a stepwise, multi-phase design, combining a two- parallel-group pilot study and a three-arm randomized controlled trial (RCT) to evaluate the appropriateness, feasibility, acceptability, and effectiveness of the AI-PEF (Figure 5). Participants will be recruited from the neurosurgery clinics at Tri-Service General Hospital, Taipei. Recruitment will be facilitated through referrals by attending physicians and registered nurses, who will be briefed on the study protocol.
Study procedures
- Phase I (Year 1): Development and Pilot Testing (Aim 1) Phase I will focus on developing and refining the AI-PEF through expert validation and pilot testing. This phase will use a sequential-parallel hybrid design to develop and evaluate the appropriateness of the AI-PEF to deliver personalized exercise empowerment. Stage 1, Delphi Process for AI-PEF Development: Ten experts from diverse fields will participate in two Delphi rounds to finalize the AI-PEF framework. This includes refining algorithms, educational materials, and preliminary validation of key components, such as personalization algorithms and behavior-change strategies. Stage 2, Small-Scale Pilot Study (Early Feedback): A single-arm pilot study with 5 patients will be conducted over four weeks to gather feedback on usability, engagement, and content clarity.
- Phase II : Larger Pilot Study (Aim 2) Phase II will focus on evaluating the feasibility, acceptability, and preliminary effectiveness of the refined AI-PEF intervention. A two-parallel-group design will be employed, with 30 participants, 15 participants per group, randomly assigned in a 1:1 ratio to the AI-PEF group and Active control group. Over three months, AI-PEF participants will engage in personalized exercise guided by AI, while active control participants will follow standard exercise recommendations. Both qualitative and quantitative data will be collected. Assessments will occur at baseline (T0) and 3 months (T1), including fitness tracker data, questionnaires (motivation, sleep, symptoms), and semi-structured interviews. The primary outcome of interest will be adherence rates, while secondary outcomes will focus on motivation and various health metrics.
- Phase III : Full- scale three-arm RCT (Aim 3) Phase III will assess the long-term impact of the AI-PEF on exercise adherence, motivation, and health outcomes through a 3-arm RCT, in which participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) the AI-PEF group, receiving a machine learning-powered personalized exercise program; (2) the Theory-based digital exercise group, engaging in structured digital exercise without machine learning-powered feedback; or (3) the Active control group, receiving general exercise recommendations as part of standard care. Participants will receive group-specific interventions during the 12-week intervention period and will be followed for six months, with assessments conducted at baseline (T1), 1 month (T2), 2 months (T3), 3 months (T4), and the 6-month follow-up (T5).
Primary outcomes will include exercise adherence, exercise motivation, mHealth app usability, and functional capacity. Exercise adherence will be objectively measured via Garmin fitness trackers; exercise motivation and mHealth app usability will be assessed through standardized questionnaires; and functional capacity will be evaluated using the 6-Minute Walk Test. Secondary outcomes, such as sleep quality, depressive symptoms, concussion symptoms, and quality of life, will also be assessed through standardized questionnaires. These standardized questionnaires are being used in our current digital remote exercise trial in patients with mild TBI (NSTC 112-2314-B-016-007-MY2) and have demonstrated good psychometric performance.
Quantitative and qualitative data will be collected and analyzed in parallel.Quantitative data will be used to compare adherence, motivation, usability, functional capacity, and health outcomes across the three groups and to evaluate the efficacy of AI-PEF relative to standard interventions. Qualitative interviews will explore participants' experiences and perceptions of the intervention. Procedures will adhere to the blinding and randomization protocols described in Intervention Fidelity, ensuring unbiased assignment and data collection processes. This proposed study protocol is closely aligned with those that have been successfully implemented in our previous digital exercise trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase 2: Evaluate the feasibility, acceptability, and preliminary effectiveness of the AI-PEF in improving patient outcomes. Phase 3: Examine the impact of the AI-PEF on exercise adherence and health outcomes
| Arm | Type | Receives |
|---|---|---|
| AI-PEF | Experimental | Behavioral: AI-PEFthe AI-PEF group, receiving a machine learning-powered personalized exercise program. |
| Theory-based digital exercise | Experimental | Behavioral: Theory-based digital exerciseTheory-based digital exercise group, engaging in structured digital exercise without machine learning- powered feedback. |
| Active control group | Active comparator | Behavioral: Active Controlthe Active control group, receiving general exercise recommendations as part of standard care in a 1:1:1 ratio. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible participants are patients aged over 18 with mild TBI (GCS 13-15)
- who can walk independently,
- reside in the Greater Taipei area,
- and possess sufficient Chinese or Taiwanese language proficiency to understand the trial
- complete self-administered questionnaires.
Key exclusion criteria (5 listed)
- include individuals with severe medical conditions (e.g., respiratory failure, epilepsy, psychiatric disorders), musculoskeletal or neurological impairments
- hindering physical activity in the 6-minute walk test,
- cognitive impairments (MMSE < 24),
- frontal lobe injuries or penetrating injury causing significant psychological dysfunction.
- Patients regularly engaging in moderate-to-high-intensity aerobic exercise or participating in other studies will also be excluded to avoid bias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-PEFParticipants will follow a 12-week walking program with at least three 30-minute sessions per week, with exercise intensity progressively adjusted based on heart rate and effort indices. Garmin fitness trackers will monitor exercise adherence and intensity. Remote guidance will be provided through five AI-generated digital health messages per week via LINE, delivered on Monday, Tuesday, Thursday, Friday, and Saturday, and tailored to participants' exercise performance and individualized goals established during the remote exercise intervention and consultation. The messages will include exercise performance feedback, goal setting and reinforcement, exercise and device-use reminders, health education, and encouragement and support. The digital component will allow participants to share their progress and seek guidance during scheduled in-person consultations. AI-driven digital feedback provides a convenient and accessible approach to supporting participants in engaging in exercise. | Behavioural | AI-PEF |
| Theory-based digital exerciseThe theory-based digital exercise group will follow the same in-person clinic visits, assessment schedule, and 12-week walking program as the AI-PEF group. Garmin fitness trackers will be used to monitor exercise adherence and intensity. The research team will deliver five standardized digital health messages per week through the LINE app using message templates developed in advance. The messages will include exercise guidance, goal setting and reinforcement, exercise and device-use reminders, health education and lifestyle recommendations, and encouragement and support. The messages will not be generated or tailored by AI, and participants will not receive AI-driven personalized feedback. | Behavioural | Theory-based digital exercise |
| Active ControlParticipants in the active control group will receive standard TBI care, including routine clinic visits. In addition, Garmin fitness trackers will be provided for self-monitoring during the study. The research team will deliver five standardized general health messages per week through the LINE app. The messages will include TBI-related health education, general health and lifestyle information, general recommendations for daily physical activity, general check-in messages, and technical reminders for Garmin use. The messages will not include structured exercise guidance, individualized goal setting or reinforcement, performance-based feedback, or AI-generated personalized feedback. Participants completing the 6-month protocol will have the option to access the AI-PEF program after the study. | Behavioural | Active control group |
Primary outcome
Adherence
Time frame: T1-baseline
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Adherence
Time frame: T2- 1 month later
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Adherence
Time frame: T3- 2 month later
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Adherence
Time frame: T4- 3 month later
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
Adherence
Time frame: T5- 6 month later
Exercise adherence will be defined as the percentage of prescribed sessions completed during the 12-week intervention, based on three 30-minute sessions per week (36 sessions in total). The Garmin Vivosmart 5 will record exercise frequency, duration, and intensity. A session will be considered completed when the participant exercises for at least 30 minutes and reaches Garmin heart rate zone 2 or higher. Adherence will be calculated by summing completed sessions, with a maximum of three sessions counted per week, dividing by 36, and multiplying by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence. Borg Rating of Perceived Exertion (RPE) will complement intensity assessment, particularly for older participants or those with heart rate or blood pressure concerns. An RPE of ≥12 indicates moderate intensity, while ≥11 may be encouraged initially, followed by gradual progression as tolerated.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T1- baseline
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T2- 1 month later
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T3- 2 month later
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T4- 3 month later
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The Chinese Version of the Sport Motivation Scale-II
Time frame: T5- 6 month later
The Chinese version of the Sport Motivation Scale-II (CSMS-II) will be used to assess six types of motivation: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. The scale consists of 18 items rated on a 7-point Likert scale from 1 to 7. The subscales include intrinsic motivation (items 3, 9, and 17), integrated regulation (items 4, 11, and 14), identified regulation (items 6, 12, and 18), introjected regulation (items 1, 7, and 16), external regulation (items 5, 8, and 15), and amotivation (items 2, 10, and 13). Each subscale is scored separately by calculating the mean of its three items. Each subscale score ranges from 1 to 7, with higher scores indicating a stronger level of the corresponding motivational regulation.
The mHealth App usability questionnaire
Time frame: T1- baseline
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
The mHealth App usability questionnaire
Time frame: T2- 1 month later
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
The mHealth App usability questionnaire
Time frame: T3- 2 month later
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
The mHealth App usability questionnaire
Time frame: T4- 3 month later
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
The mHealth App usability questionnaire
Time frame: T5- 6 month later
The Mobile App Usability Questionnaire (MAUQ) assesses usability across three dimensions: usability and satisfaction, system information arrangement, and system efficiency. A Chinese version of the questionnaire was developed in 2022, with an internal consistency reliability (Cronbach's α) of 0.988 and an internal consistency range of 0.845-0.931. The test-retest reliability ranges from 0.828 to 0.918. A total of 21 items, Likert scale scores ranged from 1 (strongly agree) to 7 (strongly disagree), indicating the lower scores the better usability.
6-Minute Walk Test
Time frame: T1- baseline
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
6-Minute Walk Test
Time frame: T2- 1 month later
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
6-Minute Walk Test
Time frame: T3- 2 month later
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
6-Minute Walk Test
Time frame: T4- 3 month later
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
6-Minute Walk Test
Time frame: T5- 6 month later
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT), which measures the distance walked in six minutes as an indicator of functional exercise capacity. A longer walking distance indicates better functional capacity.
55 secondary outcomes
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T1- baseline
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T2- 1 month later
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T3- 2 month later
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T4- 3 month later
The Rivermead Post-Concussion Symptoms Questionnaire
Time frame: T5- 6 month
The Beck Depression Inventory-II
Time frame: T1- baseline
The Beck Depression Inventory-II
Time frame: T2-1 month later
The Beck Depression Inventory-II
Time frame: T3- 2 month later
The Beck Depression Inventory-II
Time frame: T4-3 month later
The Beck Depression Inventory-II
Time frame: T5- 6 month later
The Pittsburgh Sleep Quality Index
Time frame: T1-baseline
The Pittsburgh Sleep Quality Index
Time frame: T2- 1 month later
The Pittsburgh Sleep Quality Index
Time frame: T3-2 month later
The Pittsburgh Sleep Quality Index
Time frame: T4-3 month later
The Pittsburgh Sleep Quality Index
Time frame: T5-6 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T1 -baseline
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T2 -1 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T3 -2 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T4-3 month later
The Godin-Shephard Leisure Time Physical Activity Questionnaire
Time frame: T5-6 month later
The World Health Organization Quality of Life Scale-brief
Time frame: T1 - baseline
The World Health Organization Quality of Life Scale-brief
Time frame: T2 - 1 month later
The World Health Organization Quality of Life Scale-brief
Time frame: T3 - 2 month later
The World Health Organization Quality of Life Scale-brief
Time frame: T4 - 3 month later
The World Health Organization Quality of Life Scale-brief
Time frame: T5- 6 month later
Mini-Mental State Examination
Time frame: T1- baseline
Mini-Mental State Examination
Time frame: T2-1 month later
Mini-Mental State Examination
Time frame: T3-2 month later
Mini-Mental State Examination
Time frame: T4-3 month later
Mini-Mental State Examination
Time frame: T5- 6 month later
Montreal Cognitive Assessment
Time frame: T1-baseline
Montreal Cognitive Assessment
Time frame: T2-1 month later
Montreal Cognitive Assessment
Time frame: T3-2 month later
Montreal Cognitive Assessment
Time frame: T4-3 month later
Montreal Cognitive Assessment
Time frame: T5-6 month later
Near-Infrared Brain Blood Flow Imaging
Time frame: T1 - baseline
Near-Infrared Brain Blood Flow Imaging
Time frame: T2- 1 month later
Near-Infrared Brain Blood Flow Imaging
Time frame: T3-2 month later
Near-Infrared Brain Blood Flow Imaging
Time frame: T4- 3 month later
Near-Infrared Brain Blood Flow Imaging
Time frame: T5- 6 month later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing AI-PEF and Theory-based digital exercise in people with Traumatic Brain Injury and Exercise, run by National Defense Medical Center, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Hsun Chiang, Professor (886-2-87923100 ext. 18761, sheisvivian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: T1-baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.