Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients

Not Applicable

Completed

• Conditions: Patients Waiting for Elective Coronary Artery Bypass Graft Surgery
• Interventions: Behavioral: Prehab

• Registration Number: NCT01914094
• Lead Sponsor: St. Boniface Hospital

Brief Summary

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.

Detailed Description

This was a single-centre, parallel randomized controlled trial conducted in Canada to determine the feasibility and efficacy of an exercise and education "pre-habilitation" (i.e., Prehab) program before elective coronary artery bypass graft surgery (CABG). We recruited 17 patients who were scheduled to undergo elective CABG surgery from February 2011-May 2012. Enrolled patients were assessed at baseline, one week pre-operatively, and three months post-operatively.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehab	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.

Primary Outcome Measures

Name	Time	Method
Change in 6-minute walking distance	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.

Secondary Outcome Measures

Name	Time	Method
Change in depressive symptoms	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.
Change in 5-meter gait speed	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.
Change in objectively measured physical activity	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.
Change in quality of life	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.
Change in exercise self-efficacy	Baseline; 1 week pre-operatively; 3 months post-operatively	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.
Change in cardiac anxiety	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.

Trial Locations

Locations (1)

Reh-Fit Centre; 🇨🇦 Winnipeg, Manitoba, Canada