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

Study Overview
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Brief Summary
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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)

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: Fitbit Charge HR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 Dementia 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fitbit Charge HR<br>Use of the 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. All patients will wear the Actigraph wGT3X-BT, from which data is extracted. Actigraph does not provide patient any feedback. | Device: Fitbit Charge HR<br>* 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.<br>|
| No Intervention: No Device<br>No Fitbit used and no feedback on exercise goal adherence. All patients will wear the Actigraph wGT3X-BT, from which data is extracted. Actigraph does not provide patient any feedback. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in average number of steps taken per day |  | Baseline and 12 weeks after completion of cardiac rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in average daily energy expenditure measured in % change in the average number of calories (kcal) expended per day | Average daily energy expenditure will be measured in kcal/day by the Actigraph wGT3X-BT device. | 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 | Activity bouts will be measured as periods of continuous activity recorded by the Actigraph wGT3X-BT device. | 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 | Sedentary bouts will be measured as periods of prolonged inactivity recorded by the Actigraph wGT3X-BT device. Non-wear time periods are excluded from this analysis. | 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 %. | Sleep efficiency will be measured in % using data from the Actigraph wGT3X-BT device. | 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 | change in weekly time of moderate/vigorous physical activity (MVPA, defined as activity intensity of ≥3.0 metabolic equivalents [MET] or ≥100 steps/min) (minutes). | 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 | change in quality of life (as assessed by the Short Form Health (SF36) questionnaire). | Baseline and 12 weeks after completion of cardiac rehabilitation | 
| Relative change in indicators of depression, measured in % change in PHQ9 questionnaire score | change in indicators of depression (as assessed by the Patient Health (PHQ9) questionnaire). | Baseline and 12 weeks after completion of cardiac rehabilitation | 
| Relative change in medication adherence, measured in % change in MMAS questionnaire score | change in medication adherence (as assessed by the Morisky Medication Adherence Scale (MMAS-8). | 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 BMI |  | 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 | 
| Relative change in waist circumference |  | Baseline and 12 weeks after completion of cardiac rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Transluminal Coronary Intervention, Cardiac Rehabilitation, Fitbit Charge HR