Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR … (NCT02788929) | Clinical Trial Compass
UnknownNot Applicable
Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device
40 participantsStarted 2016-05
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relative change in average number of steps taken per day
Timeframe: Baseline and 12 weeks after completion of cardiac rehabilitation