The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408327
• Other study ID #: KMUHIRB-SV(I)-20150091
• Status: Completed
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2020
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

1. 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

2. living in the community and receiving community-based mental health rehabilitation services

3. having stable psychiatric conditions (i.e., primary psychiatric medications had not changed for more than two months)

4. being 20 to 64 years old

5. No obvious cognitive impairment (Mini-Mental Status Exam >24)

6. can follow the research process and sign the consent

Exclusion Criteria:

1. having a clinically significant physical condition making it unsafe to increase daily walking activity, such as severe coronary heart disease or musculoskeletal problems

2. 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

3. uncontrolled hypertension with SBP> 160 mmHg or DBP> 110 mmHg

4. has significant cognitive impairment

5. unconscious or confused

6. already exercising regularly (i.e., doing moderate-intensity physical activities for 150 minutes each week)

7. participating in other intervention studies

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice
• Physical Activity
• Schizophrenia

Intervention

Device:
• Wearable technology
Fitness wristband & APP

Behavioral:
• LINE group
Promote social interaction
• Group activities
Which was developed by applying social cognitive theory

Device:
• Health promotion manual
Which was about general physical activity promotion content

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective daily physical activity data	Using the fitness wristband App to view the daily step counts.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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).	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary	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.).	Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)