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

Primary Purpose

Schizophrenia, Physical Activity, Health Knowledge, Attitudes, Practice

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Wearable technology
LINE group
Group activities
Health promotion manual
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring Schizophrenia, Physical Activity, Health Promotion, Wearable Technology, Fitness Wristband, mobile health, mHealth

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Wearable technology (fitness wristband & App) 4 times group activities (2 hr / each times) LINE group interaction Reminder and feedback form researcher

Wearable technology (fitness wristband + App) Health promotion manual

Outcomes

Primary Outcome Measures

Objective daily physical activity data
Using the fitness wristband App to view the daily step counts.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.).

Full Information

First Posted
January 1, 2018
Last Updated
November 5, 2020
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03408327
Brief Title
The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Physical Activity, Health Knowledge, Attitudes, Practice
Keywords
Schizophrenia, Physical Activity, Health Promotion, Wearable Technology, Fitness Wristband, mobile health, mHealth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Wearable technology (fitness wristband & App) 4 times group activities (2 hr / each times) LINE group interaction Reminder and feedback form researcher
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Wearable technology (fitness wristband + App) Health promotion manual
Intervention Type
Device
Intervention Name(s)
Wearable technology
Intervention Description
Fitness wristband & APP
Intervention Type
Behavioral
Intervention Name(s)
LINE group
Intervention Description
Promote social interaction
Intervention Type
Behavioral
Intervention Name(s)
Group activities
Intervention Description
Which was developed by applying social cognitive theory
Intervention Type
Device
Intervention Name(s)
Health promotion manual
Intervention Description
Which was about general physical activity promotion content
Primary Outcome Measure Information:
Title
Objective daily physical activity data
Description
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)
Secondary Outcome Measure Information:
Title
Subjective daily physical activity data
Description
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)
Title
Body composition
Description
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)
Title
Cardiorespiratory fitness
Description
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)
Title
Muscular strength
Description
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)
Title
Leg muscular strength and endurance
Description
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)
Title
Balance and mobility
Description
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)
Title
Attention and processing speed
Description
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)
Title
Verbal working memory
Description
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)
Title
Cognitive flexibility
Description
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)
Title
Self-efficacy in exercise
Description
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)
Title
Attitude to exercise
Description
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)
Title
Behavior of exercise goal setting
Description
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)
Title
The situation encountered during exercise
Description
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)
Title
The situation of social support
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-De Chen, Ph.D.
Organizational Affiliation
Department of Occupational Therapy, Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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