The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness
NCT03408327, Not applicable, Completed, Kaohsiung Medical University Chung-Ho Memorial Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness | ClinicalTrials.gov |
| NCT number | NCT03408327 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital | ClinicalTrials.gov |
| Conditions | Schizophrenia, Physical Activity, Health Knowledge, Attitudes, Practice | ClinicalTrials.gov |
| Interventions | Wearable technology, LINE group, Group activities, Health promotion manual | ClinicalTrials.gov |
| First posted | 2018-01-24 | ClinicalTrials.gov |
| Last updated | 2020-11-06 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Objective daily physical activity data | 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. | ClinicalTrials.gov |
| Secondary | Subjective daily physical activity data | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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). | ClinicalTrials.gov |
| Secondary | Body composition | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Cardiorespiratory fitness | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Muscular strength | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Leg muscular strength and endurance | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Balance and mobility | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Attention and processing speed | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Verbal working memory | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Cognitive flexibility | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Self-efficacy in exercise | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Attitude to exercise | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | Behavior of exercise goal setting | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | The situation encountered during exercise | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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. | ClinicalTrials.gov |
| Secondary | The situation of social support | Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test) | 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.). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)