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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Sherry Grace, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01019135
First received: November 20, 2009
Last updated: October 28, 2015
Last verified: October 2015
Results First Received: June 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions: Myocardial Ischemia
Acute Coronary Syndrome
Heart Disease
Coronary Artery Disease
Intervention: Behavioral: Cardiac Rehabilitation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Women-Only Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Co-ed Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Home-Based Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models

Participant Flow:   Overall Study
    Women-Only Cardiac Rehabilitation     Co-ed Cardiac Rehabilitation     Home-Based Cardiac Rehabilitation  
STARTED     55     59     55  
COMPLETED     35     40     24  
NOT COMPLETED     20     19     31  
Did not receive allocated intervention                 12                 6                 25  
Did not attend CR                 8                 13                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Women-Only Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Co-ed Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Home-Based Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Total Total of all reporting groups

Baseline Measures
    Women-Only Cardiac Rehabilitation     Co-ed Cardiac Rehabilitation     Home-Based Cardiac Rehabilitation     Total  
Number of Participants  
[units: participants]
  55     59     55     169  
Age  
[units: years]
Mean (Standard Deviation)
  66.22  (10.21)     61.56  (9.73)     63.13  (10.94)     63.64  (10.42)  
Gender, Customized  
[units: participants]
       
Females     55     59     55     169  
Race/Ethnicity, Customized  
[units: participants]
       
White     26     32     32     90  
Other     29     27     23     79  
Region of Enrollment  
[units: participants]
       
Canada     55     59     55     169  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Exercise Capacity   [ Time Frame: 6 months ]

3.  Secondary:   Exercise   [ Time Frame: 6 months ]

4.  Secondary:   Self-reported Exercise   [ Time Frame: 6 months ]

5.  Secondary:   Diet   [ Time Frame: 6 months ]

6.  Secondary:   Medication Adherence   [ Time Frame: 6 months ]

7.  Secondary:   Smoking   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sherry L Grace
Organization: University Health Network & York University
phone: 416.736.2100 ext 22364
e-mail: sgrace@yorku.ca


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sherry Grace, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01019135     History of Changes
Other Study ID Numbers: Cardiac Rehab for Women
Study First Received: November 20, 2009
Results First Received: June 23, 2015
Last Updated: October 28, 2015
Health Authority: Canada: Ethics Review Committee