Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device
NCT ID: NCT02788929
Last Updated: 2016-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2016-05-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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 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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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North Texas Veterans Healthcare System
FED
Responsible Party
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Emmanouil Brilakis
Director of Cardiac Catheterization Laboratories, Professor of Medicine
Principal Investigators
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Emmanouil S Brilakis, MD, PhD
Role: STUDY_CHAIR
North Texas Veterans Healthcare System
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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16-008
Identifier Type: -
Identifier Source: org_study_id
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