INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device: the INCENTIVE Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Relative change in average number of steps taken per day
研究概览
简要总结
Design: Single center, prospective, randomized study that will compare activity levels in patients who complete cardiac rehabilitation after clinically indicated percutaneous coronary intervention with and without use of the wrist-worn Fitbit Charge HR device and mobile platform application.
Primary Endpoint: The average number of steps taken per day will serve as the main marker of daily physical activity.
Control: Patients who do not receive the device (Fitbit Charge HR).
Secondary Endpoints: (1) change in daily energy expenditure (2) change in number of activity and sedentary bouts (3) change in sleep efficiency (4) change in weekly time of moderate/vigorous physical activity (5) change in quality of life (6) change in indicators of depression (7) change in medication adherence(8) change in HDL and LDL cholesterol (9) change in BMI and waist circumference (10) change in resting heart rate and blood pressure (11) change in exercise stress test performance (timeframe for all: baseline - 12 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age 18 years or greater
- •Willing and able to give informed consent
- •Successful, clinically-indicated PCI with no plan for staged procedure
- •Clinically stable and able to exercise
- •Access to smartphone (Apple or Android platform)
- •Completed 10 weeks of CR and is expected to graduate program.
排除标准
- •Plan for PCI or other major surgical procedure, which would limit exercise capability, within the 14 weeks following study enrollment.
- •Home oxygen requirement
- •Amputation, peripheral arterial disease, other musculoskeletal or neurological disease affecting mobility
- •End-stage renal disease
- •Ongoing Unstable angina or CCS IV angina
- •NYHA IV heart failure
- •Terminal illness
- •Fall risk (inability to hold semi-tandem stance for 10 seconds)
- •Pregnant women and prisoners
- •Any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.
结局指标
主要结局
Relative change in average number of steps taken per day
时间窗: Baseline and 12 weeks after completion of cardiac rehabilitation
次要结局
- Relative change in average daily energy expenditure measured in % change in the average number of calories (kcal) expended per day(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in average number of daily activity bouts measured in % change in the average number of activity bouts per day(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in average number of daily sedentary bouts measured in % change in the average number of sedentary bouts per day(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in average daily sleep efficiency measured in % change in average sleep efficiency. Sleep efficiency will also be measured in %.(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in quality of life, measured in % change in SF-36 health survey questionnaire score(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in BMI(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in average weekly moderate/vigorous physical activity, measured in % change in minutes spent in moderate/vigorous physical activity per week(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in HDL and LDL cholesterol(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in waist circumference(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in indicators of depression, measured in % change in PHQ9 questionnaire score(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in medication adherence, measured in % change in MMAS questionnaire score(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in resting heart rate(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in exercise stress test performance(Baseline and 12 weeks after completion of cardiac rehabilitation)
- Relative change in blood pressure (BP)(Baseline and 12 weeks after completion of cardiac rehabilitation)
研究者
Emmanouil Brilakis
Director of Cardiac Catheterization Laboratories, Professor of Medicine
North Texas Veterans Healthcare System