SchizophreniaNCT03408327
The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness
A study testing Wearable technology, LINE group and Group activities in people with Schizophrenia and Physical Activity, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The object is to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI Stage I: Accuracy, Acceptability, Feasibility. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Schizophrenia, Physical Activity, Health Knowledge, Attitudes, Practice
- What is being tested?
- Wearable technology, LINE group and Group activities
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2018to 31 Jul 2020
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- having a diagnosis of SMI (including schizophrenia, depression, and bipolar disorder over one year) made by a psychiatrist on the basis of the criteria set Diagnostic and Statistical Manual of Mental Disorders, 5th edition, text-revision, DSM-V
- living in the community and receiving community-based mental health rehabilitation services
- having stable psychiatric conditions (i.e., primary psychiatric medications had not changed for more than two months)
- being 20 to 64 years old
- No obvious cognitive impairment (Mini-Mental Status Exam >24)
- can follow the research process and sign the consent
Who cannot join
- having a clinically significant physical condition making it unsafe to increase daily walking activity, such as severe coronary heart disease or musculoskeletal problems
- according participants' self-statement, having following illness, including severe heart failure,myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, COPD, poor glycemic control (i.e., dialysis, diabetic neuropathy or retinopathy) and lower extremity arthritis
- uncontrolled hypertension with SBP> 160 mmHg or DBP> 110 mmHg
- has significant cognitive impairment
- unconscious or confused
- already exercising regularly (i.e., doing moderate-intensity physical activities for 150 minutes each week)
- participating in other intervention studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness- Accuracy, Acceptability, Feasibility and Effectiveness Analysis
The object is to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI
Stage I: Accuracy, Acceptability, Feasibility. Stage II: Effectiveness Analysis
In stage II, will conduct a single-blinded, randomized controlled study. 90 participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up. The measurements include physical activity level, physical fitness, cognitive function and sleep quality, as well as the moderators of the effectiveness of program.
Read the detailed description
Background: The health condition of individuals with chronic mental illness (MI) is usually poorer than the general population. This health disparity may be related to their lower physical activity level. One of the critical issues in psychiatric rehabilitation is to develop a health promotion program which utilizes less clinical resources and results in long-term effectiveness. Compared with structure exercise, lifestyle physical activity might be one of the solutions. With the mobile technology and wearable technology becoming popular, mobile health (mHealth) emerges and has showed some preliminary effects on other population. The mHealth may be an innovative health promotion program for people with MI and deserves more research to examine the effectiveness.
Purpose: This study is (1) to examine the accuracy and acceptability of wearable technology in persons with MI; (2) to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI ; (3) to examine the effectiveness of the program on physical activity level and health outcomes ; and (4) to examine the moderators of the program's effectiveness.
Methods:
Stage I: completed (Accuracy, Acceptability, Feasibility) Stage II: (RCT) The investigators will conduct a single-blinded, randomized controlled study. 90 participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up. The measurements include physical activity level, physical fitness, cognitive function and sleep quality, as well as the moderators of the effectiveness of program.
Contributions: The results of study will be one of the evidence-based health promotion programs for individuals with MI. With wearable technology and telecommunication technology, it makes possible to expand the health care services from traditional clinical settings to client's natural milieu, and to serve more people with MI by using less resources. The results of study may also form a much appreciated basis for future studies of mHealth on other heath behavior (e.g., healthy diet) or in other disability groups (e.g., stroke).
- Being tested
- Wearable technology, LINE group, Group activities, Health promotion manual
- Keywords
- Schizophrenia, Physical Activity, Health Promotion, Wearable Technology, Fitness Wristband, mobile health, mHealth
- Medical subject headings
- Schizophrenia, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable technologyDevice
Fitness wristband \& APP
LINE groupBehavioural
Promote social interaction
Group activitiesBehavioural
Which was developed by applying social cognitive theory
Health promotion manualDevice
Which was about general physical activity promotion content
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1. Wearable technology (fitness wristband \& App)
2. 4 times group activities (2 hr / each times)
3. LINE group interaction
4. Reminder and feedback form researcher Receives: Device: Wearable technology; Behavioral: LINE group; Behavioral: Group activities |
| Control group | Active comparator | 1. Wearable technology (fitness wristband + App)
2. Health promotion manual Receives: Device: Wearable technology; Device: Health promotion manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective daily physical activity data
Using the fitness wristband App to view the daily step counts.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary outcomes (14)
Subjective daily physical activity data
International Physical Activity Questionnaire-Taiwan(IPAQ-TW), it is a self-reported questionnaire to survey participants' physical activity data in pass 7 days. There are total seven questions to check the physical activity time in seven life domains, including work, housework, gardening, transportation , leisure, exercise and siting activity. After the survey, researcher will convert the data in to quantitative data in order to calculate participants' metabolic equivalent (MET·min).
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Body composition
Using Body Mass Index (BMI) as the measurement of body composition, which weight and height will be combined to report BMI in kg/m^2.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Cardiorespiratory fitness
Using 6-minute walk test (6MWT) as the measurement, which let the participant walk as far as possible over a total of six minutes on hard and flat floor. And researcher will measure the distance that participant walk in 6 minutes.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Muscular strength
Hand-grip dynamometer to test the muscular strength of upper limb.The participant holds the dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. The units is in kg.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Leg muscular strength and endurance
Using 30-Second Sit to Stand Test. The participant will sit in the middle of the chair, and rise to a full standing position, then sit back down again. Repeat this for 30 seconds.And researcher will count the times.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Balance and mobility
The Timed Up and Go test (TUG). It measure the time that the participant takes to rise from a chair, walk eight foots, turn around, walk back to the chair, and sit down.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Attention and processing speed
Symbol digit modalities test (SDMT), which makes the participant to pair specific numbers with given geometric figures as fast as possible in 90 seconds. The researcher will record the total, correct and wrong answer numbers.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Verbal working memory
Digit span test, which researcher will read a sequence of numerical digits, and the participant may to recall the sequence correctly. There are two part of this test, one is given forwards, other is backwards. these are in order to test the participant 's maximal memory span. Total scores is sum of forwards and backwards test, between 0 to 30.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Cognitive flexibility
Stroop color word test. In this test, the participant will read out the color of the word as fast as possible. Instead of read the word meaning. The scoring is the number of correct answer.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Self-efficacy in exercise
Self-Efficacy for Exercise Scale (SEES) is a self-report survey. It is used to evaluate the degree of participant's self-efficacy in exercise. There are total 9 descriptions, and participant will answer the degree of confidence (1-10 points). The scoring is used average as record, so the scale scores ranges is between 1 to 10. The higher values represent a better outcome.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Attitude to exercise
Outcome Expectations for Exercise Scale (OEES) is a self-report survey. It is used to evaluate participant's attitude to exercise. There are total 9 descriptions, and participant will answer the degree of agreement. Statements are rated 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of all nine items,so the scale scores ranges is between 9 to 45. The higher values represent a better outcome.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Behavior of exercise goal setting
Exercise Goal Setting Scale (EGS) is a self-report survey. It is used to evaluate participant's attitude to exercise. There are total 10 descriptions, and participant will answer the degree of agreement. Statements are rated 1 (strongly disagree) to 5 (strongly agree). This scoring is used average as record, so the scale scores ranges is between 1 to 5. The higher values represent a better outcome.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
The situation encountered during exercise
Exercise Benefits/Barriers Scale (EBBS) is a self-report survey. It is used to evaluate 29 items of exercise benefits and 14 items of possible exercise barriers. There are total 43 descriptions, and participant will answer the degree of agreement. Statements are rated 1 (strongly disagree) to 4 (strongly agree). When the Benefits Scale is used alone, the score range is between 29 and 116.The higher the score, the more positively the individual perceives exercise. On the other hand, when the Barriers Scale is used alone, scores range between 14 and 56. If used alone, the higher the score on the Barriers Scale, the greater the perception of barriers to exercise.
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
The situation of social support
Social Support and Exercise Survey (SSES) is a self-report survey. It is used to evaluate participant's exercise performance change from family and friends' influence. There are 13 items of behaviors that family or friends do during last 3 months, which might be benefits or barriers of participant exercise regularly, and participant will answer the degree of frequency. Statements are rated 1 (none) to 4 (very often).The survey should be scored differently for friends and family. Family Participation: sum items 1~6 and 10~13 (scores ranges is between 10 to 40. The higher values represent a better outcome.)；Family Rewards and Punishment (an optional scale): sum items 7~9 (scores ranges is between 3 to 12. The lower values represent a better outcome.)；Friend Participation: sum items 1~6 and 10~13 (scores ranges is between 10 to 40. The higher values represent a better outcome.).
Measured: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start16 Mar 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Model description
- We will conduct a single-blinded, randomized controlled study. Ninety participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-De Chen, Ph.D., Principal investigator, Department of Occupational Therapy, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408327
- Sponsor's protocol ID
- KMUHIRB-SV(I)-20150091
- Status last verified
- Nov 2020
- First submitted
- 1 Jan 2018
- Last updated
- 6 Nov 2020
- 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness- Accuracy, Acceptability, Feasibility and Effectiveness Analysis
- ClinicalTrials.gov ID
- NCT03408327
- Acronym / sponsor ID
- KMUHIRB-SV(I)-20150091
- Keywords
- Schizophrenia, Physical Activity, Health Promotion, Wearable Technology, Fitness Wristband, mobile health, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 24 Jan 2018 (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 object is to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI
Stage I: Accuracy, Acceptability, Feasibility. Stage II: Effectiveness Analysis
In stage II, will conduct a single-blinded, randomized controlled study. 90 participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up. The measurements include physical activity level, physical fitness, cognitive function and sleep quality, as well as the moderators of the effectiveness of program.
Detailed description
Background: The health condition of individuals with chronic mental illness (MI) is usually poorer than the general population. This health disparity may be related to their lower physical activity level. One of the critical issues in psychiatric rehabilitation is to develop a health promotion program which utilizes less clinical resources and results in long-term effectiveness. Compared with structure exercise, lifestyle physical activity might be one of the solutions. With the mobile technology and wearable technology becoming popular, mobile health (mHealth) emerges and has showed some preliminary effects on other population. The mHealth may be an innovative health promotion program for people with MI and deserves more research to examine the effectiveness.
Purpose: This study is (1) to examine the accuracy and acceptability of wearable technology in persons with MI; (2) to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI ; (3) to examine the effectiveness of the program on physical activity level and health outcomes ; and (4) to examine the moderators of the program's effectiveness.
Methods:
Stage I: completed (Accuracy, Acceptability, Feasibility) Stage II: (RCT) The investigators will conduct a single-blinded, randomized controlled study. 90 participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up. The measurements include physical activity level, physical fitness, cognitive function and sleep quality, as well as the moderators of the effectiveness of program.
Contributions: The results of study will be one of the evidence-based health promotion programs for individuals with MI. With wearable technology and telecommunication technology, it makes possible to expand the health care services from traditional clinical settings to client's natural milieu, and to serve more people with MI by using less resources. The results of study may also form a much appreciated basis for future studies of mHealth on other heath behavior (e.g., healthy diet) or in other disability groups (e.g., stroke).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We will conduct a single-blinded, randomized controlled study. Ninety participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Wearable technology, Behavioral: LINE group, Behavioral: Group activities1. Wearable technology (fitness wristband \& App) 2. 4 times group activities (2 hr / each times) 3. LINE group interaction 4. Reminder and feedback form researcher |
| Control group | Active comparator | Device: Wearable technology, Device: Health promotion manual1. Wearable technology (fitness wristband + App) 2. Health promotion manual |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- having a diagnosis of SMI (including schizophrenia, depression, and bipolar disorder over one year) made by a psychiatrist on the basis of the criteria set Diagnostic and Statistical Manual of Mental Disorders, 5th edition, text-revision, DSM-V
- living in the community and receiving community-based mental health rehabilitation services
- having stable psychiatric conditions (i.e., primary psychiatric medications had not changed for more than two months)
- being 20 to 64 years old
- No obvious cognitive impairment (Mini-Mental Status Exam >24)
Key exclusion criteria (7 listed)
- having a clinically significant physical condition making it unsafe to increase daily walking activity, such as severe coronary heart disease or musculoskeletal problems
- according participants' self-statement, having following illness, including severe heart failure,myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, COPD, poor glycemic control (i.e., dialysis, diabetic neuropathy or retinopathy) and lower extremity arthritis
- uncontrolled hypertension with SBP> 160 mmHg or DBP> 110 mmHg
- has significant cognitive impairment
- unconscious or confused
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 |
|---|---|---|
| Wearable technologyFitness wristband \& APP | Device | Control group, Experimental group |
| LINE groupPromote social interaction | Behavioural | Experimental group |
| Group activitiesWhich was developed by applying social cognitive theory | Behavioural | Experimental group |
| Health promotion manualWhich was about general physical activity promotion content | Device | Control group |
Primary outcome
Objective daily physical activity data
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Using the fitness wristband App to view the daily step counts.
14 secondary outcomes
Subjective daily physical activity data
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Body composition
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Cardiorespiratory fitness
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Muscular strength
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Leg muscular strength and endurance
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Balance and mobility
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Attention and processing speed
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Verbal working memory
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Cognitive flexibility
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Self-efficacy in exercise
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Attitude to exercise
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Behavior of exercise goal setting
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
The situation encountered during exercise
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
The situation of social support
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
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 6 Nov 2020.
- 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. This study is not recruiting at the moment.
Ming-De Chen, Ph.D. principal investigator
Department of Occupational Therapy, Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable technology, LINE group and Group activities in people with Schizophrenia and Physical Activity, run by Kaohsiung Medical University Chung-Ho Memorial Hospital 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 6 Nov 2020. 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?
Objective daily physical activity data (time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)). 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 6 Nov 2020.