The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation

NCT ID: NCT01658683

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 451 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2018-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Exercise Facilitator Intervention

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

Group Type: EXPERIMENTAL

Exercise Facilitator Intervention

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Reid, MBA, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Sherry Grace, PhD

Role: PRINCIPAL_INVESTIGATOR

Peter Munk Cardiac Centre

Andrew Pipe, MD

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Caroline Chessex, MD, MSc

Role: STUDY_CHAIR

Peter Munk Cardiac Centre

Chris Blanchard, PhD

Role: STUDY_CHAIR

Dalhousie University

Murray Krahn, MD, MSc

Role: STUDY_CHAIR

University of Toronto, Toronto Health Economics and Technology Assessment Collaborative

Doug Manuel, MD

Role: STUDY_CHAIR

Institute for Clinical Evaluative Sciences

Kori Kingsbury, MSN, MPA

Role: STUDY_CHAIR

Cardiac Care Network of Ontario

Jennifer Harris, BSc, PT

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Kerri-Anne Mullen, MSc

Role: STUDY_CHAIR

Institute for Clinical Evaluative Sciences

Amy Mark, PhD

Role: STUDY_CHAIR

Ottawa Heart Institute Research Corporation

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

York University and University Health Network

Toronto, Ontario, Canada

Countries

Canada

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Other Identifiers

201200579-01

Identifier Type: -

Identifier Source: org_study_id