Status:
COMPLETED
Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
Lead Sponsor:
St. Boniface Hospital
Conditions:
Patients Waiting for Coronary Artery Bypass Graft Surgery
Patients Waiting for Aortic Valve Repair or Replacement
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education...
Detailed Description
PREHAB will be a three centre prospective, randomized, open, blinded endpoint (PROBE) controlled trial using assessor blinding and intention-to-treat analysis. The study will be conducted at three aca...
Eligibility Criteria
Inclusion
- Patients aged 60 years and older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair/replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures
- Patients with Clinical Frailty Score (CFS) ≥3 (vulnerable) and \< 7 (8 = very severely frail, approaching end-of-life or 9 = terminally ill) at time of acceptance for cardiac surgery
- Patients with an estimated ≥ 6 week wait time
Exclusion
- Patients who have unstable or recent unstable cardiac syndrome as defined by:
- Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms
- Critical left main (LM) coronary disease
- Hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome prior to randomization
- Patients who have severe left ventricular obstructive disease as defined by:
- Severe aortic or mitral stenosis (aortic or mitral valve area \<1.0cm2 or mean gradient \> 40 mmHg or \> 10 mmHg respectively)
- Dynamic left ventricular (LV) outflow obstruction
- Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias
- Patients who have cognitive deficits that would preclude rehabilitation
- Patients who have physical limitations that would preclude rehabilitation
- Patients who are unable to attend the Prehab program
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02219815
Start Date
April 1 2015
End Date
June 30 2018
Last Update
October 29 2024
Active Locations (5)
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1
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H2A6
2
Saint John Regional Hospital - New Brunswick Heart Centre
Saint John, New Brunswick, Canada, E2L4L2
3
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H3A7
4
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8