Acute Coronary Syndrome Clinical Trial
Official title:
INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device: the INCENTIVE Trial
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)
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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