Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02788929
Status:
UNKNOWN
Last Update Posted:
2016-06-02
First Post:
2016-05-20
Brief Title:
Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device
Sponsor:
North Texas Veterans Healthcare System
Organization:
North Texas Veterans Healthcare System
Study Overview
Official Title:
INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device the INCENTIVE Trial
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCENTIVE
Brief 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 moderatevigorous physical activity 5 change in quality of life 6 change in indicators of depression 7 change in medication adherence8 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
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 moderatevigorous physical activity 5 change in quality of life 6 change in indicators of depression 7 change in medication adherence8 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None