- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01914094
Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients
Low levels of physical fitness increase the risk of death in patients with cardiovascular disease. Although cardiac rehabilitation programs improve the health of patients after heart surgery, most patients are not referred until after surgery. Therefore, the purpose of this study was to determine if an exercise "pre-habilitation" (i.e., Prehab) program before heart surgery would improve the health of patients before surgery and whether these improvements would be maintained after surgery.
The investigators hypothesized that Prehab would promote the health of patients before heart surgery, and these improvements would be maintained three months post-operatively, as compared to patients who received standard care.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3M 3V8
- Reh-Fit Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- On elective waitlist for coronary artery bypass graft surgery with a minimum anticipated wait time of 4-6 weeks or more
- No history of unstable angina
- Canadian Cardiovascular Society score of less than 4
- No history of myocardial infarction within the past 7 days
- Ejection fraction greater than 30%
- No history of dementia or psychiatric problems
- No self-reported dizziness or confusion
- Able to read, speak, and understand English
- Previously sedentary (reporting accumulating less than 45 minutes of moderate intensity physical activity per day on at least three days per week over the last three months)
- No previous participation in cardiac rehabilitation
- Lives in Winnipeg, Manitoba, Canada or has easy access to the Reh-Fit Centre (local medical fitness facility)
Exclusion Criteria:
- If patients cannot attend Prehab due to geographical limitations
- If patients cannot participate due to physical limitations
- Diagnosis of exercise-induced arrhythmia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
Received current standard care.
|
|
Experimental: Prehab
Received pre-operative exercise therapy plus education classes concerning management of their risk factors for coronary artery disease at a local medical fitness facility.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 6-minute walking distance
Time Frame: Baseline; 1 week pre-operatively; 3 months post-operatively
|
Assessed using the 6-minute walking test.
Output is distance.
Change from baseline 6-minute walking distance was assessed at each follow-up time point.
|
Baseline; 1 week pre-operatively; 3 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 5-meter gait speed
Time Frame: Baseline; 1 week pre-operatively; 3 months post-operatively
|
Assessed using the 5-meter gait speed test.
Output is seconds.
Change from baseline 5-meter gait speed was assessed at each follow-up time point.
|
Baseline; 1 week pre-operatively; 3 months post-operatively
|
Change in objectively measured physical activity
Time Frame: Baseline; 1 week pre-operatively; 3 months post-operatively
|
Measured by accelerometry.
Output is minutes of moderate-vigorous as well as total physical activity per week.
Change from baseline physical activity was assessed at each follow-up time point.
|
Baseline; 1 week pre-operatively; 3 months post-operatively
|
Change in quality of life
Time Frame: Baseline; 1 week pre-operatively; 3 months post-operatively
|
Self-reported using the Short Form-36 questionnaire.
Output is a summary score across eight dimensions: General health, Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Pain, Emotional well-being, and Social functioning.
Change from baseline quality of life measures was assessed at each follow-up time point.
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Baseline; 1 week pre-operatively; 3 months post-operatively
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Change in depressive symptoms
Time Frame: Baseline; 1 week pre-operatively; 3 months post-operatively
|
Assessed using the Patient Health Questionnaire-9.
Output was a numerical and categorical score.
Change from baseline depressive symptoms was assessed at each follow-up time point.
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Baseline; 1 week pre-operatively; 3 months post-operatively
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Change in exercise self-efficacy
Time Frame: Baseline; 1 week pre-operatively; 3 months post-operatively
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Assessed by the Cardiac Exercise Self-efficacy Index.
Output was a numerical score.
Change from baseline exercise self-efficacy was assessed at each follow-up time point.
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Baseline; 1 week pre-operatively; 3 months post-operatively
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Change in cardiac anxiety
Time Frame: Baseline; 1 week pre-operatively; 3 months post-operatively
|
Assessed by the Cardiac Anxiety Questionnaire.
Outputs were numerical scores across four dimensions: Fear, Avoidance, Heart-Focused Attention, and Total Score.
Change from baseline cardiac anxiety was assessed at each follow-up time point.
|
Baseline; 1 week pre-operatively; 3 months post-operatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H2010:390
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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