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

NCT ID: NCT03408327

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2020-07-31

Brief Summary

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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

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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).

Conditions

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Schizophrenia Physical Activity Health Knowledge, Attitudes, Practice

Keywords

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Schizophrenia Physical Activity Health Promotion Wearable Technology Fitness Wristband mobile health, mHealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Wearable technology

Intervention Type DEVICE

Fitness wristband \& APP

LINE group

Intervention Type BEHAVIORAL

Promote social interaction

Group activities

Intervention Type BEHAVIORAL

Which was developed by applying social cognitive theory

Control group

1. Wearable technology (fitness wristband + App)
2. Health promotion manual

Group Type ACTIVE_COMPARATOR

Wearable technology

Intervention Type DEVICE

Fitness wristband \& APP

Health promotion manual

Intervention Type DEVICE

Which was about general physical activity promotion content

Interventions

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Wearable technology

Fitness wristband \& APP

Intervention Type DEVICE

LINE group

Promote social interaction

Intervention Type BEHAVIORAL

Group activities

Which was developed by applying social cognitive theory

Intervention Type BEHAVIORAL

Health promotion manual

Which was about general physical activity promotion content

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-De Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational Therapy, Kaohsiung Medical University

Locations

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Kaohsiung Medical University

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUHIRB-SV(I)-20150091

Identifier Type: -

Identifier Source: org_study_id