Patients Waiting for Elective Coronary Artery Bypass Graft Surgery Clinical Trial
Official title:
Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients
| NCT number | NCT01914094 |
| Other study ID # | H2010:390 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2011 |
| Est. completion date | February 2013 |
| Verified date | April 2023 |
| Source | St. Boniface Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Reh-Fit Centre | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| St. Boniface Hospital |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in 6-minute walking distance | 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 | Change in 5-meter gait speed | 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 | |
| Secondary | Change in objectively measured physical activity | 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 | |
| Secondary | Change in quality of life | 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. | Baseline; 1 week pre-operatively; 3 months post-operatively | |
| Secondary | Change in depressive symptoms | 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. | Baseline; 1 week pre-operatively; 3 months post-operatively | |
| Secondary | Change in exercise self-efficacy | 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. | Baseline; 1 week pre-operatively; 3 months post-operatively | |
| Secondary | Change in cardiac anxiety | 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 |