NCT02788929

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)

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 20, 2016

Last Update Submit

May 27, 2016

Conditions

Acute Coronary Syndrome

Keywords

Percutaneous Transluminal Coronary InterventionCardiac RehabilitationFitbit Charge HR

Outcome Measures

Primary Outcomes (1)

  • Relative change in average number of steps taken per day

    Baseline and 12 weeks after completion of cardiac rehabilitation

Secondary Outcomes (14)

  • Relative change in average daily energy expenditure measured in % change in the average number of calories (kcal) expended per day

    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

    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

    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 %.

    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

    Baseline and 12 weeks after completion of cardiac rehabilitation

  • +9 more secondary outcomes

Study Arms (2)

Fitbit Charge HR

ACTIVE COMPARATOR

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 Device

NO INTERVENTION

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.

Interventions

Fitbit Charge HRDEVICE

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.

Fitbit Charge HR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 22064601BACKGROUND

  • 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.

    PMID: 21576654BACKGROUND

  • 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.

    PMID: 12576911BACKGROUND

  • 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.

    PMID: 20128541BACKGROUND

  • 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.

    PMID: 16472039BACKGROUND

  • 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.

    PMID: 18029834BACKGROUND

  • 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.

    PMID: 15829777BACKGROUND

  • 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.

    PMID: 17911274BACKGROUND

  • 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.

    PMID: 15617619BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Emmanouil S Brilakis, MD, PhD

    North Texas Veterans Healthcare System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiac Catheterization Laboratories, Professor of Medicine

Study Record Dates

First Submitted

May 20, 2016

First Posted

June 2, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Last Updated

June 2, 2016

Record last verified: 2016-05