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

NCT01914094 | Completed

• 1 other identifier: H2010:390
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Waiting for Elective Coronary Artery Bypass Graft Surgery

Keywords

Preoperative care; Exercise therapy; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in 5-meter gait speed

  Baseline; 1 week pre-operatively; 3 months post-operatively

• Change in objectively measured physical activity

  Baseline; 1 week pre-operatively; 3 months post-operatively

• Change in quality of life

  Baseline; 1 week pre-operatively; 3 months post-operatively

• Change in depressive symptoms

  Baseline; 1 week pre-operatively; 3 months post-operatively

• Change in exercise self-efficacy

  Baseline; 1 week pre-operatively; 3 months post-operatively

Study Arms (2)

Standard care

NO INTERVENTION

Received current standard care.

Prehab

EXPERIMENTAL

Received pre-operative exercise therapy plus education classes concerning management of their risk factors for coronary artery disease at a local medical fitness facility.

Behavioral: Prehab

Interventions

Prehab BEHAVIORAL

Also known as: Pre-habilitation, Preoperative exercise therapy

Prehab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• If patients cannot attend Prehab due to geographical limitations
• If patients cannot participate due to physical limitations
• Diagnosis of exercise-induced arrhythmia

Sponsors & Collaborators

• St. Boniface Hospital: lead

Study Sites (1)

Reh-Fit Centre

Winnipeg, Manitoba, R3M 3V8, Canada

Location

Study Officials

• Jo-Ann V Sawatzky, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Rakesh C Arora, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Intensive Care Cardiac Sciences

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: August 1, 2013
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

CA (1)