Cardiac Rehabilitation for Heart Event Recovery (HER)
CR4HER
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])
1 other identifier
interventional
169
1 country
5
Brief Summary
The purpose of this study is to compare women's cardiac rehabilitation program adherence across three program models.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 20, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
November 30, 2015
CompletedNovember 30, 2015
October 1, 2015
4.3 years
November 20, 2009
June 23, 2015
October 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CR Program Adherence
6 months
Secondary Outcomes (6)
Exercise Capacity
6 months
Exercise
6 months
Self-reported Exercise
6 months
Diet
6 months
Medication Adherence
6 months
- +1 more secondary outcomes
Study Arms (3)
Women-Only Cardiac Rehabilitation
ACTIVE COMPARATORThe 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.
Co-ed Cardiac Rehabilitation
ACTIVE COMPARATORThe 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.
Home-Based Cardiac Rehabilitation
ACTIVE COMPARATORIn 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.
Interventions
comparison of multiple cardiac rehabilitation program models
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hamilton Health Sciences Centre
Hamilton, Ontario, L8N3Z5, Canada
Mount Sinai
Toronto, Ontario, M3K 1G5, Canada
Toronto Rehabilitation Institute
Toronto, Ontario, M4G1R7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
University Health Network
Toronto, Ontario, M5G2C4, Canada
Related Publications (1)
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.
PMID: 26682921DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sherry L Grace
- Organization
- University Health Network & York University
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research
Study Record Dates
First Submitted
November 20, 2009
First Posted
November 25, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
November 30, 2015
Results First Posted
November 30, 2015
Record last verified: 2015-10