An interventional study of Fitbit Charge HR in Acute Coronary Syndrome, sponsored by North Texas Veterans Healthcare System. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-02.
Sponsored by North Texas Veterans Healthcare System · Not applicable, Interventional, and Supportive care
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)
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →North Texas Veterans Healthcare System is the lead sponsor of 31 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Relative change in average number of steps taken per day
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Relative change in BMI
Time frame: 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
Relative change in exercise stress test performance
Time frame: 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
Relative change in waist circumference
Time frame: Baseline and 12 weeks after completion of cardiac rehabilitation
No study locations are listed for this record.
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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North Texas Veterans Healthcare System