Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Amount of time spent sedentary based on activity counts
研究概览
简要总结
Researchers are trying to assess exercise patterns during and after cardiac rehabilitation participation and to compare changes in blood markers and the microbiome before and after rehabilitation.
详细描述
Study participation involves a visit to Mayo Clinic at 6 months and 1 year after you begin cardiac rehabilitation. In addition to the standard of care cardiac rehab program, which consists of 36 full sessions, you would be randomized to an activity monitor group or a usual care group.
If randomized to the activity monitor group you will receive a FitBit and will be asked to wear this during cardiac rehabilitation and for one year after you complete the program; complete 4 blood draws (at the start of rehab, at the end of rehab, 6 months after finishing rehab and 1 year after completing rehab) and complete questionnaires about your lifestyle, sleep, mood. The data from the FitBit will be sent to the study team for one year.
If randomized to the usual care group you will complete 4 blood draws (at the start of rehab, at the end of rehab, 6 months after rehab, and 1 year after completing rehab); and complete questionnaires about your lifestyle, sleep, mood.
If you agree to be in the study, you will be asked to wear monitors with capabilities to detect your heart rate or physical activity for up to 1 year. Data will be acquired from the monitors or remote device accounts.
You will also be asked to fill out questionnaires about your current level of physical activity, dietary intake, mood, stress, motivation, and quality of life.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 years and older
- •English speaking
- •Able to provide consent
- •Has a qualifying indication for cardiac rehabilitation (ie. Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, and stable angina), owns a smart phone and able to download the fitness monitor app (and willing to have their data downloaded from their fitness monitor after completion of cardiac rehab), and able to participate in cardiac rehabilitation.
排除标准
- •Does not own a smart phone or is unwilling to download the app or is unable to participate in cardiac rehab.
研究组 & 干预措施
Usual Care Group
The usual care group will NOT receive a FitBit
干预措施: usual care group (Behavioral)
Activity Monitor Group
This arm will receive a FitBit and will be asked to wear this for one year
干预措施: activity monitor group (Behavioral)
结局指标
主要结局
Amount of time spent sedentary based on activity counts
时间窗: 1 year
Objective measure of sedentary time using an accelerometer (activity count levels)
Physical activity measured by Fitbit (steps)
时间窗: 1 year
Objective measure of physical activity during cardiac rehabilitation participation and for one year after using a Fitbit and Fitabase.
Change in plasma ceramides
时间窗: 1 year
Examine the effect of cardiac rehabilitation on plasma ceramide levels
次要结局
- Microbiome changes following an exercise program - Cardiac Rehab(15 months)
研究者
Amanda R. Bonikowske
Principal Investigator
Mayo Clinic