Physical ActivityNCT07767136
Structured Self-Talk and Wearable-Assisted Walking for Physical Activity and Function in Older Adults
A study testing Moderate-Intensity Walking Program, Wearable Activity Device and Structured Self-Talk Training in people with Physical Activity and Physical Function, run by CHENG-EN WU at 1 site in Taiwan.
Trial summary
The goal of this randomized clinical trial was to examine whether adding structured self-talk to wearable-assisted walking could support physical activity and physical function in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Physical Function, Healthy Aging
- What is being tested?
- Moderate-Intensity Walking Program, Wearable Activity Device and Structured Self-Talk Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- -
- Aged 65 years or older. Community-dwelling and independent in activities of daily living. Able to ambulate safely without physical assistance; use of a cane was permitted.
- Cleared for participation in moderate-intensity physical activity using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
- Montreal Cognitive Assessment (MoCA) score of 24 or higher. Sufficient literacy and communication ability in Chinese to understand study instructions and complete study procedures.
- Access to a smartphone and an internet connection. Able to independently perform basic smartphone and wearable-device operations, including charging the wearable device.
- Willing to wear the study wearable device and comply with the intervention procedures.
Who cannot join
- A medically treated fall within the previous 3 months. A major cardiovascular event within the previous 6 months. Lower-extremity surgery within the previous 6 months. Severe neuromuscular disease that could interfere with safe participation or outcome assessment.
- Severe visual or auditory impairment that could interfere with communication or study assessments.
- Use of medications known to substantially affect cognitive function or muscle performance.
- Concurrent participation in another structured exercise or rehabilitation program.
- A medical contraindication to moderate-intensity exercise, including unstable chronic medical conditions as determined by a healthcare professional.
- Severe psychiatric disorder or cognitive impairment that could interfere with adherence to study procedures.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Integrating Self-Talk Strategies With Wearable Technology on Physical Activity, Functional Performance, and Psychological Determinants in Community-Dwelling Older Adults: A Randomized Controlled Trial
The goal of this randomized clinical trial was to examine whether adding structured self-talk to wearable-assisted walking could support physical activity and physical function in community-dwelling older adults. The study also examined whether wearable-assisted walking provided benefits compared with a walking program without wearable feedback.
Participants were randomly assigned to one of three groups for 12 weeks: (1) wearable-assisted walking combined with structured self-talk, (2) wearable-assisted walking without structured self-talk, or (3) a walking-only active control condition. All groups followed the same moderate-intensity walking schedule.
The main questions were whether wearable-assisted walking was associated with better physical activity and functional performance than walking alone, and whether adding structured self-talk provided additional benefits beyond wearable-assisted walking. Physical activity, functional performance, and other protocol-specified health-related measures were assessed before and after the intervention.
Read the detailed description
This was a 12-week, three-arm, parallel-group randomized controlled trial conducted in community-dwelling older adults. Sixty participants were allocated in a 1:1:1 ratio to an integrated intervention group, a technology-assisted group, or an active control group.
All three groups followed the same moderate-intensity walking prescription consisting of three 30-minute sessions per week for 12 weeks, with exercise intensity guided by a rating of perceived exertion of 11-13. The integrated intervention group used a wearable activity device that provided real-time activity feedback and also received structured self-talk training. The self-talk component was designed to help participants use task-focused and motivational statements during walking and progressed from awareness and instruction to regulation and self-directed use over the intervention period.
The technology-assisted group followed the same walking prescription and used the same wearable activity device but did not receive structured self-talk training. The active control group followed the same walking prescription without wearable feedback or structured self-talk and recorded exercise participation using a paper-based log.
Assessments were conducted at baseline and after completion of the 12-week intervention. Outcome assessors were blinded to group allocation. The study was designed to distinguish the effects associated with wearable-assisted walking from any additional effects associated with adding structured self-talk.
- Conditions
- Physical Activity, Physical Function, Healthy Aging
- Being tested
- Moderate-Intensity Walking Program, Wearable Activity Device, Structured Self-Talk Training
- Keywords
- Structured Self-Talk, Wearable Technology, Walking Exercise, Community-Dwelling Older Adults, Physical Activity, Functional Performance, Muscle Strength, Body Composition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Walking ProgramBehavioural
Participants performed moderate-intensity walking three times per week for 30 minutes per session over 12 weeks. Exercise intensity was prescribed at a rating of perceived exertion (RPE) of 11-13. This standardized walking program was provided to participants in all three study groups.
Wearable Activity DeviceDevice
A wrist-worn wearable activity device was used to provide real-time step feedback and haptic vibration alerts during the 12-week walking intervention. The device was used as a behavioral feedback tool to support walking participation. Data from the intervention wearable device were not used as the research outcome measure.
Structured Self-Talk TrainingBehavioural
Participants received weekly structured self-talk training throughout the 12-week intervention. The training was delivered by trained instructors and progressed through four stages: awareness, acquisition, regulation, and maintenance. Participants were taught to use structured motivational and instructional self-talk during walking and in response to wearable-generated feedback. Standardized scripts and fidelity checklists were used to support consistent intervention delivery.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Intervention Group | Experimental | Participants received a 12-week moderate-intensity walking program combined with wearable-based activity feedback and structured self-talk training. Walking was prescribed three times per week for 30 minutes per session at a rating of perceived exertion of 11-13. The wearable device provided real-time step feedback and haptic alerts. Structured self-talk training was provided weekly and progressed through awareness, acquisition, regulation, and maintenance stages. Receives: Behavioral: Moderate-Intensity Walking Program; Device: Wearable Activity Device; Behavioral: Structured Self-Talk Training |
| Technology-Assisted Group | Active comparator | Participants received the same 12-week moderate-intensity walking program and used the same wearable device for real-time activity feedback but did not receive structured self-talk training. Brief weekly contacts were limited to device operation, battery status, and wearing compliance and did not include psychological strategy training. Receives: Behavioral: Moderate-Intensity Walking Program; Device: Wearable Activity Device |
| Active Control Group | Active comparator | Participants received the same 12-week moderate-intensity walking program without wearable-based activity feedback or structured self-talk training. Participants recorded the date, duration, and rating of perceived exertion of each walking session using a paper-based exercise log. Receives: Behavioral: Moderate-Intensity Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time Spent in Moderate-to-Vigorous Physical Activity
Time spent in moderate-to-vigorous physical activity was assessed using a research-grade ActiGraph triaxial accelerometer during 7-day monitoring periods at baseline and after the 12-week intervention.
Measured: Baseline and 12 weeks
Average Daily Step Count
Average daily step count was measured using a research-grade ActiGraph triaxial accelerometer worn on the non-dominant wrist. Daily steps were summarized across valid monitoring days at baseline and after the 12-week intervention. Higher values indicate greater daily physical activity.
Measured: Baseline and 12 weeks
Five-Times Sit-to-Stand
Lower-extremity functional performance was assessed using the five-times sit-to-stand test. Completion time was recorded in seconds, with shorter times indicating better performance.
Measured: Baseline and 12 weeks
Handgrip Strength
Upper-extremity muscle strength was assessed using dominant-hand grip strength. Strength was recorded in kilograms, with higher values indicating greater grip strength.
Measured: Baseline and 12 weeks
Timed Up and Go
Dynamic balance and mobility were assessed using the Timed Up and Go test. Completion time was recorded in seconds, with shorter times indicating better performance.
Measured: Baseline and 12 weeks
Appendicular Skeletal Muscle Mass Index
Appendicular skeletal muscle mass index (ASMI) was assessed using an InBody 370S bioelectrical impedance analyzer and calculated as appendicular skeletal muscle mass divided by height squared (kg/m²). Higher values indicate greater appendicular muscle mass relative to height.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Exercise Self-Efficacy
Exercise self-efficacy was assessed using the Exercise Self-Efficacy Scale (ESES), which evaluates confidence in continuing exercise under challenging situations. Higher scores indicate greater exercise self-efficacy.
Measured: Baseline and 12 weeks
Exercise Motivation / Behavioral Regulation
Exercise motivation and internalization were assessed using a behavioral regulation in exercise questionnaire to evaluate the degree of autonomous motivation toward exercise.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start15 Mar 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHENG-EN WU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHENG-EN WU, National Taiwan College of Performing Arts
- Investigators
- CHENG-EN WU, phd, Principal investigator, National Taiwan College of Performing Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767136
- Sponsor's protocol ID
- IRB115-029-BA
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the informed consent obtained for this study did not include unrestricted public sharing of individual-level participant data. De-identified aggregate data may be provided upon reasonable request, subject to applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Integrating Self-Talk Strategies With Wearable Technology on Physical Activity, Functional Performance, and Psychological Determinants in Community-Dwelling Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07767136
- Acronym / sponsor ID
- IRB115-029-BA
- Conditions
- Physical Activity, Physical Function, Healthy Aging
- Keywords
- Structured Self-Talk, Wearable Technology, Walking Exercise, Community-Dwelling Older Adults, Physical Activity, Functional Performance, Muscle Strength, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CHENG-EN WUUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Aug 2026 (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.
The goal of this randomized clinical trial was to examine whether adding structured self-talk to wearable-assisted walking could support physical activity and physical function in community-dwelling older adults. The study also examined whether wearable-assisted walking provided benefits compared with a walking program without wearable feedback.
Participants were randomly assigned to one of three groups for 12 weeks: (1) wearable-assisted walking combined with structured self-talk, (2) wearable-assisted walking without structured self-talk, or (3) a walking-only active control condition. All groups followed the same moderate-intensity walking schedule.
The main questions were whether wearable-assisted walking was associated with better physical activity and functional performance than walking alone, and whether adding structured self-talk provided additional benefits beyond wearable-assisted walking. Physical activity, functional performance, and other protocol-specified health-related measures were assessed before and after the intervention.
Detailed description
This was a 12-week, three-arm, parallel-group randomized controlled trial conducted in community-dwelling older adults. Sixty participants were allocated in a 1:1:1 ratio to an integrated intervention group, a technology-assisted group, or an active control group.
All three groups followed the same moderate-intensity walking prescription consisting of three 30-minute sessions per week for 12 weeks, with exercise intensity guided by a rating of perceived exertion of 11-13. The integrated intervention group used a wearable activity device that provided real-time activity feedback and also received structured self-talk training. The self-talk component was designed to help participants use task-focused and motivational statements during walking and progressed from awareness and instruction to regulation and self-directed use over the intervention period.
The technology-assisted group followed the same walking prescription and used the same wearable activity device but did not receive structured self-talk training. The active control group followed the same walking prescription without wearable feedback or structured self-talk and recorded exercise participation using a paper-based log.
Assessments were conducted at baseline and after completion of the 12-week intervention. Outcome assessors were blinded to group allocation. The study was designed to distinguish the effects associated with wearable-assisted walking from any additional effects associated with adding structured self-talk.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integrated Intervention Group | Experimental | Behavioral: Moderate-Intensity Walking Program, Device: Wearable Activity Device, Behavioral: Structured Self-Talk TrainingParticipants received a 12-week moderate-intensity walking program combined with wearable-based activity feedback and structured self-talk training. Walking was prescribed three times per week for 30 minutes per session at a rating of perceived exertion of 11-13. The wearable device provided real-time step feedback and haptic alerts. Structured self-talk training was provided weekly and progressed through awareness, acquisition, regulation, and maintenance stages. |
| Technology-Assisted Group | Active comparator | Behavioral: Moderate-Intensity Walking Program, Device: Wearable Activity DeviceParticipants received the same 12-week moderate-intensity walking program and used the same wearable device for real-time activity feedback but did not receive structured self-talk training. Brief weekly contacts were limited to device operation, battery status, and wearing compliance and did not include psychological strategy training. |
| Active Control Group | Active comparator | Behavioral: Moderate-Intensity Walking ProgramParticipants received the same 12-week moderate-intensity walking program without wearable-based activity feedback or structured self-talk training. Participants recorded the date, duration, and rating of perceived exertion of each walking session using a paper-based exercise log. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- -
- Aged 65 years or older. Community-dwelling and independent in activities of daily living. Able to ambulate safely without physical assistance; use of a cane was permitted.
- Cleared for participation in moderate-intensity physical activity using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
- Montreal Cognitive Assessment (MoCA) score of 24 or higher. Sufficient literacy and communication ability in Chinese to understand study instructions and complete study procedures.
- Access to a smartphone and an internet connection. Able to independently perform basic smartphone and wearable-device operations, including charging the wearable device.
Key exclusion criteria (7 listed)
- A medically treated fall within the previous 3 months. A major cardiovascular event within the previous 6 months. Lower-extremity surgery within the previous 6 months. Severe neuromuscular disease that could interfere with safe participation or outcome assessment.
- Severe visual or auditory impairment that could interfere with communication or study assessments.
- Use of medications known to substantially affect cognitive function or muscle performance.
- Concurrent participation in another structured exercise or rehabilitation program.
- A medical contraindication to moderate-intensity exercise, including unstable chronic medical conditions as determined by a healthcare professional.
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 |
|---|---|---|
| Moderate-Intensity Walking ProgramParticipants performed moderate-intensity walking three times per week for 30 minutes per session over 12 weeks. Exercise intensity was prescribed at a rating of perceived exertion (RPE) of 11-13. This standardized walking program was provided to participants in all three study groups. | Behavioural | Active Control Group, Integrated Intervention Group, Technology-Assisted Group |
| Wearable Activity DeviceA wrist-worn wearable activity device was used to provide real-time step feedback and haptic vibration alerts during the 12-week walking intervention. The device was used as a behavioral feedback tool to support walking participation. Data from the intervention wearable device were not used as the research outcome measure. | Device | Integrated Intervention Group, Technology-Assisted Group |
| Structured Self-Talk TrainingParticipants received weekly structured self-talk training throughout the 12-week intervention. The training was delivered by trained instructors and progressed through four stages: awareness, acquisition, regulation, and maintenance. Participants were taught to use structured motivational and instructional self-talk during walking and in response to wearable-generated feedback. Standardized scripts and fidelity checklists were used to support consistent intervention delivery. | Behavioural | Integrated Intervention Group |
Primary outcome
Change in Time Spent in Moderate-to-Vigorous Physical Activity
Time frame: Baseline and 12 weeks
Time spent in moderate-to-vigorous physical activity was assessed using a research-grade ActiGraph triaxial accelerometer during 7-day monitoring periods at baseline and after the 12-week intervention.
Average Daily Step Count
Time frame: Baseline and 12 weeks
Average daily step count was measured using a research-grade ActiGraph triaxial accelerometer worn on the non-dominant wrist. Daily steps were summarized across valid monitoring days at baseline and after the 12-week intervention. Higher values indicate greater daily physical activity.
Five-Times Sit-to-Stand
Time frame: Baseline and 12 weeks
Lower-extremity functional performance was assessed using the five-times sit-to-stand test. Completion time was recorded in seconds, with shorter times indicating better performance.
Handgrip Strength
Time frame: Baseline and 12 weeks
Upper-extremity muscle strength was assessed using dominant-hand grip strength. Strength was recorded in kilograms, with higher values indicating greater grip strength.
Timed Up and Go
Time frame: Baseline and 12 weeks
Dynamic balance and mobility were assessed using the Timed Up and Go test. Completion time was recorded in seconds, with shorter times indicating better performance.
Appendicular Skeletal Muscle Mass Index
Time frame: Baseline and 12 weeks
Appendicular skeletal muscle mass index (ASMI) was assessed using an InBody 370S bioelectrical impedance analyzer and calculated as appendicular skeletal muscle mass divided by height squared (kg/m²). Higher values indicate greater appendicular muscle mass relative to height.
2 secondary outcomes
Exercise Self-Efficacy
Time frame: Baseline and 12 weeks
Exercise Motivation / Behavioral Regulation
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the informed consent obtained for this study did not include unrestricted public sharing of individual-level participant data. De-identified aggregate data may be provided upon reasonable request, subject to applicable ethical and institutional requirements.
Related trials for Physical Activity
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Recruiting
Stress Modulation and Dynamic Balance
Stress
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
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. This study is not recruiting at the moment.
CHENG-EN WU, phd principal investigator
National Taiwan College of Performing Arts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Walking Program, Wearable Activity Device and Structured Self-Talk Training in people with Physical Activity and Physical Function, run by CHENG-EN WU at 1 site in 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time Spent in Moderate-to-Vigorous Physical Activity (time frame: Baseline and 12 weeks). The study lists 6 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 17 Aug 2026.