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

NCT03408327 | Completed

• 1 other identifier: KMUHIRB-SV(I)-20150091
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Physical Activity; Health Knowledge, Attitudes, Practice

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Subjective daily physical activity data

  Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)

• Body composition

  Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)

• Cardiorespiratory fitness

  Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)

• Muscular strength

  Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)

• Leg muscular strength and endurance

  Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Device: Wearable technology; Device: Health promotion manual

Interventions

Wearable technology DEVICE

Fitness wristband \& APP

Control group; Experimental group

LINE group BEHAVIORAL

Promote social interaction

Experimental group

Group activities BEHAVIORAL

Which was developed by applying social cognitive theory

Experimental group

Health promotion manual DEVICE

Which was about general physical activity promotion content

Control group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 80756, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Motor Activity; Behavior

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Ming-De Chen, Ph.D.

  Department of Occupational Therapy, Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 24, 2018
• Study Start: March 16, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)