An interventional study of Wearable technology and LINE group in Schizophrenia, Physical Activity and Health Knowledge, Attitudes, Practice, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Other
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.
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).
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 50 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 291 studies on the registry; 58 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Wearable technology · Behavioral: LINE group · Behavioral: Group activities
1. Wearable technology (fitness wristband + App) 2. Health promotion manual
Device: Wearable technology · Device: Health promotion manual
Fitness wristband \& APP
Promote social interaction
Which was developed by applying social cognitive theory
Which was about general physical activity promotion content
Objective daily physical activity data
Using the fitness wristband App to view the daily step counts.
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.).
Time frame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Plan to share: No
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