The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation (ECOPCR)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Behavioral: Exercise Facilitator Intervention	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	451 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Prevention
Official Title:	Ecologically Optimizing Exercise Maintenance in Men and Women Post-Cardiac Rehabilitation: A Randomized Controlled Trial of Efficacy With Economics
Study Start Date :	October 2012
Actual Primary Completion Date :	March 2018
Estimated Study Completion Date :	June 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Exercise Facilitator Intervention; The intervention employs small group counseling teleconferences (5),personal telephone contacts (3) and community Heart Wise Exercise program demonstrations.	Behavioral: Exercise Facilitator Intervention; 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.
No Intervention: Usual Care; 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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 9-day accelerometer-measured physical activity of moderate and vigorous intensity [ Time Frame: 78 weeks ]
   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.

Secondary Outcome Measures :

1. Symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill [ Time Frame: 52 weeks ]
   A random sub-sample of participants (N = 124) will complete a symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill at baseline and at 52 weeks. Exercise tolerance will also be assessed using the Duke Activity Status Index (DASI), a self-administered questionnaire that measures a patient's functional capacity and is used as an estimate of an individual's peak oxygen uptake
2. Quality of life measured by the the EuroQoL 5D [ Time Frame: 78 weeks ]
   The EQ-5D is the current gold standard measure of generic quality of life, has been used in numerous studies and has been validated in many languages. The EQ-5D consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale. The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
3. Cardiovascular risk factors measured by body mass index and blood pressure. [ Time Frame: 78 weeks ]
   Height and weight is measured for the determination of body mass index (BMI). Waist circumference is measured using a non-stretchable standard tape measure. Systolic blood pressure is measured in a seated position after a five-minute rest period using an automated, non-invasive blood pressure monitor (BPTru) that automatically performs six measurements
4. Enrollment in Heart Wise Exercise programs [ Time Frame: 78 weeks ]
   Enrollment in community-based and Heart Wise Exercise programs will be queried in the follow-up surveys.
5. Mediators of Intervention Effect [ Time Frame: 78 weeks ]
   1.Physical activity history 2.Physical activity self-regulation 3. Action planning 4. Intentions to exercise 5. Beliefs about the benefits of and barriers to exercise 5. Task self-efficacy 6. Barrier self-efficacy 7. Social support from family and friends 8. Autonomy support derived from health care providers 9. Home exercise equipment 10. Neighbourhood environmental attributes of walkability and access to recreation facilities 11. Adherence to medications
6. Cost-effectiveness and cost-utility [ Time Frame: 78 weeks ]
   Health effects are measured by overall survival time; event-free time from myocardial infarction, revascularization or death; and quality adjusted life years. Participants are linked to health administrative data to allow health care utilization to be tracked. Participants complete a monthly diary to record time for counseling and physical activities, out-of-pocket expenses, and items related to productivity, including lost work days, home care expenses due to reduced function or cardiac disability. Data is collected on the resources expended for each intervention.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
York University and University Health Network
Toronto, Ontario, Canada, M5G2C4

Sponsors and Collaborators

Ottawa Heart Institute Research Corporation

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator:	Robert Reid, MBA, PhD	Ottawa Heart Institute Research Corporation
Principal Investigator:	Sherry Grace, PhD	Peter Munk Cardiac Centre
Study Chair:	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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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.

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. Erratum in: Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):747. LaHaye, Stephen A [added].

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.

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.

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.

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.

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.

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.

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.

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. Review. Update in: Cochrane Database Syst Rev. 2016;1:CD001800.

Hodges JM. Reflections: Occupational therapy. Am J Occup Ther. 1976 Aug;30(7):409-10.

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.

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.

Responsible Party:	Dr Robert Reid, Principal Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:	NCT01658683 History of Changes
Other Study ID Numbers:	201200579-01
First Posted:	August 7, 2012
Last Update Posted:	April 12, 2018
Last Verified:	April 2018

Keywords provided by Dr Robert Reid, Ottawa Heart Institute Research Corporation:

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

Additional relevant MeSH terms:

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