Clinical trial NCT01914094: Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients
Official title: Pre-habilitation Program for Elective Coronary Artery Bypass Graft Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Waiting for Elective Coronary Artery Bypass Graft Surgery
Keywords: Preoperative care
Exercise therapy
Cardiac surgery
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 6-minute walking distance
timeFrame: Baseline; 1 week pre-operatively; 3 months post-operatively
Secondary outcomes:
measure: Change in 5-meter gait speed
timeFrame: Baseline; 1 week pre-operatively; 3 months post-operatively
measure: Change in objectively measured physical activity
timeFrame: Baseline; 1 week pre-operatively; 3 months post-operatively
measure: Change in quality of life
timeFrame: Baseline; 1 week pre-operatively; 3 months post-operatively
measure: Change in depressive symptoms
timeFrame: Baseline; 1 week pre-operatively; 3 months post-operatively
measure: Change in exercise self-efficacy
timeFrame: Baseline; 1 week pre-operatively; 3 months post-operatively
measure: Change in cardiac anxiety
timeFrame: Baseline; 1 week pre-operatively; 3 months post-operatively
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Reh-Fit Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jo-Ann V Sawatzky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Rakesh C Arora, MD
role: PRINCIPAL_INVESTIGATOR
References: