Cardiac Rehabilitation for Heart Event Recovery (HER) (CR4HER)

University Health Network, Toronto

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Acute Coronary Syndrome; Heart Disease

Treatments: Behavioral: Cardiac Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01019135

Cardiac Rehab for Women

Details and patient eligibility

About

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

Full description

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.

Enrollment: 169 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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169 participants in 3 patient groups

Women-Only Cardiac Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cardiac Rehabilitation

Co-ed Cardiac Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cardiac Rehabilitation

Home-Based Cardiac Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cardiac Rehabilitation