Clinical trial NCT03408327: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Physical Activity
Health Knowledge, Attitudes, Practice
Keywords: Schizophrenia
Physical Activity
Health Promotion
Wearable Technology
Fitness Wristband
mobile health, mHealth
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Objective daily physical activity data
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Secondary outcomes:
measure: Subjective daily physical activity data
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Body composition
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Cardiorespiratory fitness
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Muscular strength
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Leg muscular strength and endurance
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Balance and mobility
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Attention and processing speed
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Verbal working memory
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Cognitive flexibility
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Self-efficacy in exercise
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Attitude to exercise
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: Behavior of exercise goal setting
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: The situation encountered during exercise
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
measure: The situation of social support
timeFrame: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Department of Occupational Therapy, Kaohsiung Medical University
name: Ming-De Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: