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

NCT ID: NCT01914094

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Patients Waiting for Elective Coronary Artery Bypass Graft Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard care

Received current standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Prehab

Intervention Type BEHAVIORAL

Interventions

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Prehab

Intervention Type BEHAVIORAL

Other Intervention Names

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Pre-habilitation Preoperative exercise therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Boniface Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rakesh C. Arora

Medical Director, Intensive Care Cardiac Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jo-Ann V Sawatzky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Rakesh C Arora, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Reh-Fit Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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H2010:390

Identifier Type: -

Identifier Source: org_study_id

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