Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
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.
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 academic, tertiary care hospitals (St. Boniface Hospital, Winnipeg, MB,
 Montreal Heart Institute. Montreal QC and Queen Elizabeth II Health Sciences Centre, Halifax,
 NS) and one non-academic hospital (Saint John Regional Health Centre, Saint John, NB) that
 perform cardiac surgery. These sites were chosen based on similar patient populations and
 surgical waitlist times. Additionally, each of these sites are partnered with one or more
 community-based cardiac rehabilitation (CR) centres, which are certified medical fitness
 facilities dedicated to improving the health of the community through health promotion,
 disease prevention and rehabilitation services. These facilities offer expert guidance from
 certified professionals, innovative health enhancement programs, and provide integrated
 medical, rehabilitative and fitness services. The investigators intend to recruit a total of
 244 participants to the study (122 per study arm), anticipating a 20% dropout rate to achieve
 an eventual sample size of 194 participants.

 Patients in the PREHAB group will receive, in addition to standard of care, an eight-week
 comprehensive exercise therapy and education program at a community-based CR facility. This
 program will target both the physical and psycho-social-cognitive aspects of cardiac disease
 and frailty. In brief, participants will be required to complete an intake health status
 assessment by the CR team including a physiotherapist, cardiovascular nurse, and dietitian
 and complete a symptom-limited graded exercise stress test according to the American College
 of Sports Medicine Guidelines for Exercise Testing and Prescription 7th Edition. Patients
 will be asked to complete at least two sessions of supervised, structured exercise class plus
 have the option to attend one additional exercise class per week for eight-weeks, with
 progression to a moderate to high-intensity interval program based on the supervised
 assessment of the patient's capabilities. This has been shown to be safe and effective in
 unrepaired heart failure and elderly patients. PREHAB participants will also attend four
 education sessions on topics such as risk factor reduction, medication use, cardiovascular
 physiology, smoking cessation, healthy eating, exercise, and stress management and promotion
 of self-managed care.
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 < 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 Criteria:

 -  Patients who have unstable or recent unstable cardiac syndrome as defined by:

 1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms

 2. Critical left main (LM) coronary disease

 3. Hospitalization for arrhythmias, congestive heart failure or acute coronary
 syndrome prior to randomization

 -  Patients who have severe left ventricular obstructive disease as defined by:

 1. Severe aortic or mitral stenosis (aortic or mitral valve area <1.0cm2 or mean
 gradient > 40 mmHg or > 10 mmHg respectively)

 2. 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