Reducing Sedentary Time in Patients With Cardiovascular Disease: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview
研究概览
简要总结
The purpose of this study is to develop and test a 12-week sedentary behavior reduction intervention ("Sit Less" program) for patients with cardiovascular disease. The program aims to reduce and break sitting times among this population using an objective activity monitor and mHealth. The investigators will test the program to help cardiovascular disease patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study whether the program leads to improvements in heart disease risk factors, and whether cardiovascular disease patients like the program and can follow it.
详细描述
The investigators propose to develop and conduct a pilot 2-arm RCT to test a wearable technology-based sedentary behavior reduction intervention in cardiovascular disease patients. Participants will be randomized to either the control group or the sedentary behavior reduction intervention group. The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.
Specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in cardiovascular patients by evaluating reach, retention, satisfaction, and compliance with the intervention; evaluate the preliminary efficacy of the sedentary behavior reduction intervention on changes in sedentary time; and explore preliminary effects of the sedentary reduction intervention on physical activity, cardiometabolic markers and patient-centered outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor and statistician will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18 and above
- •Have at least one of the following conditions including history of heart attack or peripheral artery disease or a stent placed in heart or leg
- •Self-report of sitting ≥ 8 hr/day
- •Ability to stand and walk
- •Ownership of a smartphone
排除标准
- •Currently using an activity tracker
- •Currently participating in exercise of cardiac rehabilitation programs
- •Non-English speaking
- •Patients who are classified as unstable (e.g. heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake, or any other conditions contradictory to standing or walking and
- •Currently pregnant
结局指标
主要结局
Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview
时间窗: Baseline to 12 weeks
Level of satisfaction with the intervention will be assessed by using the 10-item of system usability scale. An exit interview will be conducted by the intervention among subsamples of the intervention group (n =20) during the post-intervention visit. The interview will assess the acceptability of and satisfaction with the intervention, barriers and facilitators to sedentary behavior reduction, and any alternate strategies tried by participants during the study.
Level of compliance with the intervention assessed by number of days the Fitbit device was worn
时间窗: Baseline to 12 weeks
The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.
Changes of sedentary behavior assessed by 7 days of activPAL device monitoring
时间窗: Baseline and 12 weeks
Sedentary behavior will be assessed by three parameters including total daily sedentary time, prolonged sedentary time (time spent sitting \>30mins), and numbers of sit-to-stand transition. These three sedentary behavior parameters will be measured by 7 days of activPAL 3 device monitoring.
次要结局
- Changes of confidence in reducing sedentary behavior measured by using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.(Baseline and 12 weeks)
- Changes of habit strength for sedentary behavior assessed by using the Self-Report Habit Index.(Baseline and 12 weeks)
- Changes of physical activity measured by 7 days of activPAL device monitoring(Baseline and 12 weeks)
- Changes of cardiometabolic biomarkers measured by blood dried spot card(Baseline and 12 weeks)
- Changes of 24-hour glucose levels assessed by continuous glucose monitors(Baseline and 12 weeks)
研究者
Chorong Park
Assistant Professor
Vanderbilt University