The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness- Accuracy, Acceptability, Feasibility and Effectiveness Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Objective daily physical activity data
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Objective daily physical activity data
时间窗: Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test)
Using the fitness wristband App to view the daily step counts.
次要结局
- Attitude to exercise(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))
- Attention and processing speed(Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test))
- 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))
- Balance and mobility(Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test))
- Verbal working memory(Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test))
- Cognitive flexibility(Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test))
- Self-efficacy in exercise(Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test))
- Behavior of exercise goal setting(Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test))
- The situation encountered during exercise(Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test))
- The situation of social support(Change from baseline outcome measure at 12 weeks (post-test),and at 24 weeks (follow-up test))