NCT02788929

Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device

INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device: the INCENTIVE Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: North Texas Veterans Healthcare System · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Fitbit Charge HR	Patients randomized to the FitBit group will receive Fitbit Charge HR, a simple, user-friendly, wrist-worn, commercially available device which provides feedback on exercise goal adherence, in combination with the Fitbit mobile platform application.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• First posted: 2016-06-02
• Last updated: 2016-06-02