Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device

Acute Coronary Syndrome Clinical Trial

— INCENTIVE  

Official title:

INCreasing Exercise adhereNce After percuTaneous Coronary InterVEntion With the Fitbit Charge HR Device: the INCENTIVE Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02788929
• Other study ID #: 16-008
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 20, 2016
• Last updated: May 27, 2016
• Start date: May 2016

Study information

• Verified date: May 2016
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

References & Publications (9)

Bohannon RW. Number of pedometer-assessed steps taken per day by adults: a descriptive meta-analysis. Phys Ther. 2007 Dec;87(12):1642-50. Epub 2007 Oct 2. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Erratum in: Circulation. 2012 Feb 28;125(8):e412. Dosage error in article text. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in average number of steps taken per day		Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	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.	Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	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.	Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	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.	Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	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.	Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	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).	Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	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).	Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	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).	Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	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).	Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	Relative change in HDL and LDL cholesterol		Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	Relative change in BMI		Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	Relative change in resting heart rate		Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	Relative change in exercise stress test performance		Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	Relative change in blood pressure (BP)		Baseline and 12 weeks after completion of cardiac rehabilitation	No
Secondary	Relative change in waist circumference		Baseline and 12 weeks after completion of cardiac rehabilitation	No