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

NCT02788929 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-06-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Emmanouil S Brilakis, MD, PhD · North Texas Veterans Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788929 on ClinicalTrials.gov