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

Veterans Affairs (VA) North Texas Health Care System

Status: Unknown

Conditions: Acute Coronary Syndrome

Treatments: Device: Fitbit Charge HR

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02788929

16-008

Details and patient eligibility

About

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)

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Fitbit Charge HR

Active Comparator group

Description:

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.

Treatment:

Device: Fitbit Charge HR

No Device

No Intervention group

Description:

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.