Clinical trial NCT02788929: Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device
Official title: INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device: the INCENTIVE Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Percutaneous Transluminal Coronary Intervention
Cardiac Rehabilitation
Fitbit Charge HR
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2016-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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)


Eligibility criteria: 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.

Primary outcomes:
measure: Relative change in average number of steps taken per day
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
Secondary outcomes:
measure: Relative change in average daily energy expenditure measured in % change in the average number of calories (kcal) expended per day
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in average number of daily activity bouts measured in % change in the average number of activity bouts per day
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in average number of daily sedentary bouts measured in % change in the average number of sedentary bouts per day
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in average daily sleep efficiency measured in % change in average sleep efficiency. Sleep efficiency will also be measured in %.
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in average weekly moderate/vigorous physical activity, measured in % change in minutes spent in moderate/vigorous physical activity per week
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in quality of life, measured in % change in SF-36 health survey questionnaire score
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in indicators of depression, measured in % change in PHQ9 questionnaire score
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in medication adherence, measured in % change in MMAS questionnaire score
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in HDL and LDL cholesterol
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in BMI
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in resting heart rate
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in exercise stress test performance
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in blood pressure (BP)
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
measure: Relative change in waist circumference
timeFrame: Baseline and 12 weeks after completion of cardiac rehabilitation
Other outcomes:
Locations:
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Emmanouil S Brilakis, MD, PhD
role: STUDY_CHAIR
References:
citation: Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011 Dec 6;124(23):e574-651. doi: 10.1161/CIR.0b013e31823ba622. Epub 2011 Nov 7. No abstract available.
citation: Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.
citation: Moore SM, Dolansky MA, Ruland CM, Pashkow FJ, Blackburn GG. Predictors of women's exercise maintenance after cardiac rehabilitation. J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):40-9. doi: 10.1097/00008483-200301000-00008.
citation: Dolansky MA, Stepanczuk B, Charvat JM, Moore SM. Women's and men's exercise adherence after a cardiac event. Res Gerontol Nurs. 2010 Jan;3(1):30-8. doi: 10.3928/19404921-20090706-03. Epub 2010 Jan 27.
citation: Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9.
citation: Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
citation: Izawa KP, Watanabe S, Omiya K, Hirano Y, Oka K, Osada N, Iijima S. Effect of the self-monitoring approach on exercise maintenance during cardiac rehabilitation: a randomized, controlled trial. Am J Phys Med Rehabil. 2005 May;84(5):313-21. doi: 10.1097/01.phm.0000156901.95289.09.
citation: Bohannon RW. Number of pedometer-assessed steps taken per day by adults: a descriptive meta-analysis. Phys Ther. 2007 Dec;87(12):1642-50. doi: 10.2522/ptj.20060037. Epub 2007 Oct 2.
citation: VanWormer JJ, Boucher JL, Pronk NP, Thoennes JJ. Lifestyle behavior change and coronary artery disease: effectiveness of a telephone-based counseling program. J Nutr Educ Behav. 2004 Nov-Dec;36(6):333-4. doi: 10.1016/s1499-4046(06)60406-5. No abstract available.