The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation

NCT01658683 | Completed

• 1 other identifier: 201200579-01
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to develop a new intervention to improve the transition of patients from structured, supervised exercise to self-managed home- or approved community-based exercise programs in an effort to increase maintenance of exercise behaviour post cardiac rehabilitation (CR). The goal of the study is that those receiving the intervention will engage in at least 30 minutes of physical activity at a moderate or vigorous intensity 5 or more days per week, 26, 52 and 78 weeks after CR compared to those in the usual care group. The new intervention will be delivered by trained exercise facilitators (physiotherapists or exercise specialists) and will make use of: small group counseling teleconferences (5 sessions); personal telephone contacts (3 sessions), and community program demonstrations that would facilitate linkages between patients and approved community programs known as Heart Wise Exercise programs available in Ottawa and Toronto. The trial will be conducted at the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute and the Cardiovascular Rehabilitation and Prevention Centre at the University Health Network (Peter Munk Cardiac Centre \[PMCC\] and Toronto Rehabilitation Institute \[TRI\]) sites. The study has a target enrollment of 604 participants.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Cardiac Rehabilitation; Exercise Maintenance; Facilitator; Managed Home Exercise; Community Based Exercise

Outcome Measures

Primary Outcomes (1)

• 9-day accelerometer-measured physical activity of moderate and vigorous intensity

  Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 9-day recording period, excluding periods when they are sleeping, swimming, or bathing. The activity monitor provides measurements including activity counts, energy expenditure, and step counts, in addition to activity intensity levels. Participants will be considered to be maintaining exercise at guideline recommended levels if they undertake ≥ 30 minutes of moderate and/or vigorous intensity physical activity on ≥ five days.

  78 weeks

Secondary Outcomes (6)

• Symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill

  52 weeks

• Quality of life measured by the the EuroQoL 5D

  78 weeks

• Cardiovascular risk factors measured by body mass index and blood pressure.

  78 weeks

• Enrollment in Heart Wise Exercise programs

  78 weeks

• Mediators of Intervention Effect

  78 weeks

Study Arms (2)

Exercise Facilitator Intervention

EXPERIMENTAL

The intervention employs small group counseling teleconferences (5),personal telephone contacts (3) and community Heart Wise Exercise program demonstrations.

Behavioral: Exercise Facilitator Intervention

Usual Care

NO INTERVENTION

Usual care for cardiac rehab graduates provided by the University of Ottawa Heart Institute Minto Prevention \& Rehabilitation Centre and the Cardiovascular Rehabilitation and Prevention Centre at the University Health Network.

Interventions

Exercise Facilitator Intervention BEHAVIORAL

The 50 week intervention includes 5 small group counseling teleconferences, 3 personal telephone calls and Heart Wise Exercise program demonstrations. During the teleconferences and personal telephone calls, the facilitator discusses the importance of exercise. Participants review their activity diaries, identify barriers to exercise maintenance experienced to date and brainstorm solutions as a group. In addition, the facilitator conducts community program demonstrations at Heart Wise Exercise program locations in Ottawa and Toronto for interested participants.

Exercise Facilitator Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is currently participating in an on-site CR program of ≥ 8-week duration (to ensure that outcomes are not confounded by exposure to home-based or telephone-based case managed programs)
• Patient has graduated from CR (to ensure that the study is evaluating an intervention to help sustain and improve maintenance of exercise behaviour
• Patient has a documented diagnosis of CAD (to ensure homogeneity of the patient population)
• Patient is 18 years of age or older
• Patient is able and willing to provide informed consent
• Able to walk unaided at 2 mph

You may not qualify if:

• Patient has New York Heart Association class III or IV heart failure (because this might interfere with the ability to achieve recommended exercise levels and to ensure homogeneity of the patient population)
• Patient is pregnant, lactating or planning to become pregnant during the study period (because this might interfere with the ability to achieve recommended exercise levels)
• Patient is unable to read and understand English or French
• Planning to leave the province or region in the next 12 months
• Member of the participant's household is already participating in the study
• The participant is unable, in the opinion of the qualified investigator, to participate in unsupervised exercise.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (2)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

York University and University Health Network

Toronto, Ontario, M5G2C4, Canada

Location

Related Publications (14)

• Grace SL, Chessex C, Arthur H, Chan S, Cyr C, Dafoe W, Juneau M, Oh P, Suskin N. Systematizing Inpatient Referral to Cardiac Rehabilitation 2010: Canadian association of cardiac rehabilitation and Canadian cardiovascular society joint position paper. J Cardiopulm Rehabil Prev. 2011 May-Jun;31(3):E1-8. doi: 10.1097/HCR.0b013e318219721f.

  PMID: 21460733 BACKGROUND

• Blanchard CM, Reid RD, Morrin LI, McDonnell L, McGannon K, Rhodes RE, Spence JC, Edwards N. Demographic and clinical determinants of moderate to vigorous physical activity during home-based cardiac rehabilitation: the home-based determinants of exercise (HOME) study. J Cardiopulm Rehabil Prev. 2010 Jul-Aug;30(4):240-5. doi: 10.1097/HCR.0b013e3181d0c4ae.

  PMID: 20216322 BACKGROUND

• Reid RD, Morrin LI, Pipe AL, Dafoe WA, Higginson LA, Wielgosz AT, LeHaye SA, McDonald PW, Plotnikoff RC, Courneya KS, Oldridge NB, Beaton LJ, Papadakis S, Slovinec D'Angelo ME, Tulloch HE, Blanchard CM. Determinants of physical activity after hospitalization for coronary artery disease: the Tracking Exercise After Cardiac Hospitalization (TEACH) Study. Eur J Cardiovasc Prev Rehabil. 2006 Aug;13(4):529-37. doi: 10.1097/01.hjr.0000201513.13343.97.

  PMID: 16874141 BACKGROUND

• Blanchard CM, Courneya KS, Rodgers WM, Fraser SN, Murray TC, Daub B, Black B. Is the theory of planned behavior a useful framework for understanding exercise adherence during phase II cardiac rehabilitation? J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):29-39. doi: 10.1097/00008483-200301000-00007.

  PMID: 12576910 BACKGROUND

• Reid RD, Dafoe WA, Morrin L, Mayhew A, Papadakis S, Beaton L, Oldridge NB, Coyle D, Wells GA. Impact of program duration and contact frequency on efficacy and cost of cardiac rehabilitation: results of a randomized trial. Am Heart J. 2005 May;149(5):862-8. doi: 10.1016/j.ahj.2004.09.029.

  PMID: 15894969 BACKGROUND

• Bock BC, Carmona-Barros RE, Esler JL, Tilkemeier PL. Program participation and physical activity maintenance after cardiac rehabilitation. Behav Modif. 2003 Jan;27(1):37-53. doi: 10.1177/0145445502238692.

  PMID: 12587259 BACKGROUND

• Izawa KP, Yamada S, Oka K, Watanabe S, Omiya K, Iijima S, Hirano Y, Kobayashi T, Kasahara Y, Samejima H, Osada N. Long-term exercise maintenance, physical activity, and health-related quality of life after cardiac rehabilitation. Am J Phys Med Rehabil. 2004 Dec;83(12):884-92. doi: 10.1097/01.phm.0000143404.59050.11.

  PMID: 15624566 BACKGROUND

• Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

  PMID: 4053261 BACKGROUND

• Sallis JF, Kerr J, Carlson JA, Norman GJ, Saelens BE, Durant N, Ainsworth BE. Evaluating a brief self-report measure of neighborhood environments for physical activity research and surveillance: Physical Activity Neighborhood Environment Scale (PANES). J Phys Act Health. 2010 Jul;7(4):533-40. doi: 10.1123/jpah.7.4.533.

  PMID: 20683096 BACKGROUND

• Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005 Mar;43(3):203-20. doi: 10.1097/00005650-200503000-00003.

  PMID: 15725977 BACKGROUND

• Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.

  PMID: 21735386 BACKGROUND

• Hodges JM. Reflections: Occupational therapy. Am J Occup Ther. 1976 Aug;30(7):409-10. No abstract available.

  PMID: 782256 BACKGROUND

• 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: 15829777 BACKGROUND

• Johnson NA, Lim LL, Bowe SJ. Multicenter randomized controlled trial of a home walking intervention after outpatient cardiac rehabilitation on health-related quality of life in women. Eur J Cardiovasc Prev Rehabil. 2009 Oct;16(5):633-7. doi: 10.1097/HJR.0b013e32832e8eba.

  PMID: 19543092 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Robert Reid, MBA, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Sherry Grace, PhD

  Peter Munk Cardiac Centre

  PRINCIPAL INVESTIGATOR

• Andrew Pipe, MD

  Ottawa Heart Institute Research Corporation

  STUDY CHAIR

• Caroline Chessex, MD, MSc

  Peter Munk Cardiac Centre

  STUDY CHAIR

• Chris Blanchard, PhD

  Dalhousie University

  STUDY CHAIR

• Murray Krahn, MD, MSc

  University of Toronto, Toronto Health Economics and Technology Assessment Collaborative

  STUDY CHAIR

• Doug Manuel, MD

  Institute for Clinical Evaluative Sciences

  STUDY CHAIR

• Kori Kingsbury, MSN, MPA

  Cardiac Care Network of Ontario

  STUDY CHAIR

• Jennifer Harris, BSc, PT

  Ottawa Heart Institute Research Corporation

  STUDY CHAIR

• Kerri-Anne Mullen, MSc

  Institute for Clinical Evaluative Sciences

  STUDY CHAIR

• Amy Mark, PhD

  Ottawa Heart Institute Research Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 7, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 10, 2022

Record last verified: 2022-02

Locations

CA (2)