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N/A N=89 Randomized Single-blind Supportive Care

Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.

Patients Waiting for Coronary Artery Bypass Graft Surgery · Patients Waiting for Aortic Valve Repair or Replacement · Patients Waiting for Mitral Valve Repair or Replacement · Patients Waiting for Combined Procedures. (CAGB and Valve)

Enrolled (actual)
89
Serious AEs
3.7%
Results posted
Oct 2021
Primary outcome: Primary: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. — 20; 16 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Prehab Intervention (Behavioral)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
St. Boniface Hospital
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.
20; 16
SECONDARY
Baseline Exercise Capacity
SECONDARY
Preoperative Exercise Capacity
SECONDARY
3-Month Exercise Capacity
SECONDARY
1-Year Exercise Capacity
SECONDARY
Baseline Physical Activity Behaviour
SECONDARY
Preoperative Physical Activity Behaviour
SECONDARY
3-Month Physical Activity Behaviour
SECONDARY
1-Year Physical Activity Behaviour
SECONDARY
Baseline Health-Related Quality of Life
SECONDARY
Preoperatve Health-Related Quality of Life
SECONDARY
3-Month Health-Related Quality of Life
SECONDARY
1-Year Health-Related Quality of Life
SECONDARY
Baseline Frailty
SECONDARY
Preoperative Frailty
SECONDARY
3-Month Frailty
SECONDARY
1-Year Frailty
SECONDARY
Baseline Anxiety
SECONDARY
Preoperative Anxiety
SECONDARY
3-Month Anxiety
SECONDARY
1-Year Anxiety
SECONDARY
Baseline Depression
SECONDARY
Preoperative Depression
SECONDARY
3-Month Depression
SECONDARY
1 Year Depression
SECONDARY
Postoperative Major Adverse Events
SECONDARY
Postoperative Cardiac Rehabilitation Attendance

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 program at a community-based cardiac rehabilitation facility. Patients can wait for elective heart surgery for as long as 3-4 months. During this time, individuals are often fearful of making things worse, causing them to stop being active and further deteriorate their physical condition. This wait period presents a potential opportunity for health care providers to engage the patient to take control of their self-managed care prior to surgery with the intent of improving post-surgical outcomes. Patients randomized to the PREHAB intervention group will participate in supervised exercise twice per week in a program designed to improve physical functioning and exercise capacity. The investigators hypothesize that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will reduce frailty, improve exercise capacity, improve physical activity behaviour, improve in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and improve overall quality of life.

Eligibility Criteria

Inclusion Criteria

  • 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02219815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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