Completed

NCT Number: 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.

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Key information

Conditions

Patients Waiting for Elective Coronary Artery Bypass Graft Surgery

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reh-Fit Centre

Winnipeg, Manitoba, R3M 3V8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehab

Behavioral

Other names: Pre-habilitation, Preoperative exercise therapy

Primary outcomes

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.

Secondary outcomes

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.
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.
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.
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.
Change in exercise self-efficacy

Time frame: 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

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.

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Aug 1, 2013
Registry last updated: Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.