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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01019135
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : November 30, 2015
Last Update Posted : November 30, 2015
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Sherry Grace, University Health Network, Toronto

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

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Acute Coronary Syndrome Heart Disease Coronary Artery Disease Behavioral: Cardiac Rehabilitation Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of Women's Adherence to Women-only, Home-based and Traditional Cardiac Rehabilitation (Cardiac Rehabilitation for Her Heart Event Recovery [CR4HER])
Study Start Date : November 2009
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Cardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models

Active Comparator: 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.
Behavioral: Cardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models

Active Comparator: 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.
Behavioral: Cardiac Rehabilitation
comparison of multiple cardiac rehabilitation program models

Primary Outcome Measures :
  1. CR Program Adherence [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Exercise Capacity [ Time Frame: 6 months ]
    Exercise capacity as measured by VO2peak on a graded stress test.

  2. Exercise [ Time Frame: 6 months ]
    Mean daily steps as measured by a pedometer over 7 days

  3. Self-reported Exercise [ Time Frame: 6 months ]
    The Godin Leisure-time Exercise Questionnaire will be administered in the pre and post-test surveys. It is a brief and reliable instrument to assess usual leisure-time physical activity behaviour during a one-week period. For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Part two of the questionnaire calculates the frequency of weekly leisure-time activities pursued. Total weekly leisure activity is calculated by summing the products of the separate components. Scores begin at zero, with higher scores indicating greater physical activity. For example, scores equal to or greater than 20 are indicative of someone who is "active". There is no max score.

  4. Diet [ Time Frame: 6 months ]

    The Diet Habit Survey was used to assess diet. It is an inexpensive, reliable, and valid instrument for rapid assessment of eating habits and diet composition. Its 9 questions are related to the consumption of cholesterol, saturated fat, complex carbohydrate (including fiber), and salt.

    Greater scores indicate better diets, both for the total score and for each area. The total score indicates the level of fat in the diet (with scores equal to or greater than 236 corresponding to a low-fat diet 20% or less). Scores can begin at 56 and have no upper range.

  5. Medication Adherence [ Time Frame: 6 months ]
    The 4-item Morisky Medication Adherence Scale was used, which is scored as yes = 0, no = 1, such that a higher score indicates higher medication adherence. Scores range from 0 to 4, with patients scoring 2 or above considered adherent.

  6. Smoking [ Time Frame: 6 months ]
    Current smoking status

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01019135

Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8N3Z5
Mount Sinai
Toronto, Ontario, Canada, M3K 1G5
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M4G1R7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
University Health Network
Toronto, Ontario, Canada, M5G2C4
Sponsors and Collaborators
University Health Network, Toronto
Heart and Stroke Foundation of Ontario
Principal Investigator: Sherry L Grace, PhD University Health Network & York University
Study Chair: Heather M Arthur, PhD McMaster University
Study Chair: Paul Oh, MD Toronto Rehabilitation Institute
Study Chair: Caroline Chessex, MD University Health Network, Toronto
Study Chair: Stephanie Brister, MD University Health Network, Toronto

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sherry Grace, Director of Research, University Health Network, Toronto Identifier: NCT01019135     History of Changes
Other Study ID Numbers: Cardiac Rehab for Women
First Posted: November 25, 2009    Key Record Dates
Results First Posted: November 30, 2015
Last Update Posted: November 30, 2015
Last Verified: October 2015

Keywords provided by Sherry Grace, University Health Network, Toronto:
Cardiac Care Facilities
Patient satisfaction
Patient participation
Patient compliance
Randomized Control Trial
Coronary artery bypass
Angioplasty, transluminal, percutaneous coronary

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Acute Coronary Syndrome
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes