Cardiac Rehabilitation for Heart Event Recovery (HER)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this study is to compare women's cardiac rehabilitation program adherence across three program models.

Detailed Description

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Heart disease is the leading cause of morbidity and mortality for women in Canada. Cardiac rehabilitation (CR) is an outpatient secondary prevention program composed of structured exercise and comprehensive education and counseling. CR participation results in lower morbidity and mortality, among other benefits. Unfortunately, women are significantly less likely to adhere to these programs than men. While the traditional model of CR care is a hospital-based mixed-sex program, women are the minority in such programs, and state that these programs do not meet their care preferences. Two other models of CR care have been developed: hospital-based women-only (sex-specific) and monitored home-based programs. Other than through our controlled pilot testing of 36 patients, women's adherence to these program models is not well known.

CR4HER is a 3 parallel arm pragmatic RCT designed to compare program adherence to traditional hospital-based CR with males and females, home-based CR, and women-only hospital-based CR. Power calculations based on our pilot study suggest a sample size of 261 patients is needed to detect a difference in adherence by program model using ANCOVA. Participants are female CAD, acute coronary syndrome, percutaneous coronary intervention, bypass surgery, or valve surgery inpatients recruited from 5 hospitals. Also, female patients referred to participating cardiac rehabilitation (3) centres with one of the aforementioned diagnosis will be approached to participate. The primary outcome variable is program adherence operationalized as CR site-reported percentage of prescribed sessions completed by phone or on-site, as reported by a staff member who is blind to study objectives. Secondary outcomes are exercise capacity operationalized as VO2peak on a graded stress test, and exercise, dietary, smoking and medication adherence behaviours measured in hospital and 1 week post-CR. By identifying the CR program model which results in the greatest adherence for women, we can optimize their participation and potentially their cardiac outcomes.

Conditions

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Myocardial Ischemia Acute Coronary Syndrome Heart Disease Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Women-Only Cardiac Rehabilitation

The women-only CR programs include on-site group exercise training sessions 1-2 days/week. Participants are encouraged to walk at home on alternate days of the week. Education sessions are also given in a group format, wherein participants engage in on-site female-only group exercise sessions, as well as female-only group education sessions.

Group Type ACTIVE_COMPARATOR

Cardiac Rehabilitation

Intervention Type BEHAVIORAL

comparison of multiple cardiac rehabilitation program models

Co-ed Cardiac Rehabilitation

The traditional hospital-based co-ed CR programs include on-site group exercise training sessions 1-2 days/week. Participants are encouraged to walk at home on alternate days of the week. Education sessions are also given in a group format.

Group Type ACTIVE_COMPARATOR

Cardiac Rehabilitation

Intervention Type BEHAVIORAL

comparison of multiple cardiac rehabilitation program models

Home-Based Cardiac Rehabilitation

In the monitored home-based programs, patients attend an intake appointment where an exercise test is performed as the basis for exercise prescription. Patients are given written guidelines for aerobic conditioning based on their treadmill test. Patients are cautioned about symptoms, and taught how to check their heart rate during walking sessions. Patients are provided with reading materials regarding CVD, risk factors and lifestyle modification. These are discussed with an allied health professional from the home-based CR program by telephone during weekly scheduled telephone calls.

Group Type ACTIVE_COMPARATOR

Cardiac Rehabilitation

Intervention Type BEHAVIORAL

comparison of multiple cardiac rehabilitation program models

Interventions

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Cardiac Rehabilitation

comparison of multiple cardiac rehabilitation program models

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Documented coronary artery disease and/or acute coronary syndrome diagnosis and/or revascularization (coronary bypass graft or angioplasty) and/or valve surgery
* Work or reside in Greater Toronto Area
* Proficiency in English language
* Written approval to participate in CR by the patient's cardiac specialist or general practitioner
* Eligible for home-based CR

Exclusion Criteria

* musculoskeletal, neuromuscular, visual, cognitive or non-dysphoric psychiatric condition, or any serious or terminal illness not otherwise specified which would preclude CR eligibility based on CR guidelines
* physician deems patient not suitable for CR at time of intake exercise stress test
* planning to leave the area prior to the anticipated end of participation
* being discharged to a long-term care facility
* participation in another clinical trial with behavioral interventions

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Sherry Grace

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherry L Grace, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network & York University

Heather M Arthur, PhD

Role: STUDY_CHAIR

McMaster University

Paul Oh, MD

Role: STUDY_CHAIR

Toronto Rehabilitation Institute

Caroline Chessex, MD

Role: STUDY_CHAIR

University Health Network, Toronto

Stephanie Brister, MD

Role: STUDY_CHAIR

University Health Network, Toronto

Locations

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Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Site Status

Mount Sinai

Toronto, Ontario, Canada

Site Status

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Grace SL, Midence L, Oh P, Brister S, Chessex C, Stewart DE, Arthur HM. Cardiac Rehabilitation Program Adherence and Functional Capacity Among Women: A Randomized Controlled Trial. Mayo Clin Proc. 2016 Feb;91(2):140-8. doi: 10.1016/j.mayocp.2015.10.021. Epub 2015 Dec 10.

Reference Type DERIVED

PMID: 26682921 (View on PubMed)

Other Identifiers

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Cardiac Rehab for Women

Identifier Type: -

Identifier Source: org_study_id

Cardiac Rehabilitation for Heart Event Recovery (HER)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Women-Only Cardiac Rehabilitation

Cardiac Rehabilitation

Co-ed Cardiac Rehabilitation

Cardiac Rehabilitation

Home-Based Cardiac Rehabilitation

Cardiac Rehabilitation

Interventions

Cardiac Rehabilitation

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Heart and Stroke Foundation of Ontario

University Health Network, Toronto

Responsible Party

Sherry Grace

Principal Investigators

Sherry L Grace, PhD

Heather M Arthur, PhD

Paul Oh, MD

Caroline Chessex, MD

Stephanie Brister, MD

Locations

Hamilton Health Sciences Centre

Mount Sinai

Toronto Rehabilitation Institute

Sunnybrook Health Sciences Centre

University Health Network

Countries

References

Grace SL, Midence L, Oh P, Brister S, Chessex C, Stewart DE, Arthur HM. Cardiac Rehabilitation Program Adherence and Functional Capacity Among Women: A Randomized Controlled Trial. Mayo Clin Proc. 2016 Feb;91(2):140-8. doi: 10.1016/j.mayocp.2015.10.021. Epub 2015 Dec 10.

Other Identifiers

Cardiac Rehab for Women