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

May 27, 2016 updated by: Emmanouil Brilakis, North Texas Veterans Healthcare System

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fitbit Charge HR

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
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.
No Intervention: No Device
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?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative change in average number of steps taken per day
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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 %.
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in BMI
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in resting heart rate
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in exercise stress test performance
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in blood pressure (BP)
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Baseline and 12 weeks after completion of cardiac rehabilitation
Relative change in waist circumference
Time Frame: Baseline and 12 weeks after completion of cardiac rehabilitation
Baseline and 12 weeks after completion of cardiac rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Investigators

  • Study Chair: Emmanouil S Brilakis, MD, PhD, North Texas Veterans Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on Fitbit Charge HR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe