Clinical trial NCT02219815: Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
Official title: Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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)
Keywords: Preoperative Care
Exercise Therapy
Cardiac Surgery
Frailty
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 89
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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.

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 \< 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

Primary outcomes:
measure: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.
timeFrame: Post-surgery (approximately 9 weeks after baseline)
Secondary outcomes:
measure: Baseline Exercise Capacity
timeFrame: baseline assessment - Study entry
measure: Preoperative Exercise Capacity
timeFrame: Pre-Surgery (approximately 8 weeks after baseline)
measure: 3-Month Exercise Capacity
timeFrame: 3 Months Post-Surgery (approximately 5 months after baseline)
measure: 1-Year Exercise Capacity
timeFrame: 1 Year Post-Surgery (approximately 14 months after baseline)
measure: Baseline Physical Activity Behaviour
timeFrame: baseline assessment - Study entry
measure: Preoperative Physical Activity Behaviour
timeFrame: Pre-Surgery (approximately 8 weeks after baseline)
measure: 3-Month Physical Activity Behaviour
timeFrame: 3 Months Post-Surgery (approximately 5 months after baseline)
measure: 1-Year Physical Activity Behaviour
timeFrame: 1 Year Post-Surgery (approximately 14 months after baseline)
measure: Baseline Health-Related Quality of Life
timeFrame: baseline assessment - Study entry
measure: Preoperatve Health-Related Quality of Life
timeFrame: Pre-Surgery (approximately 8 weeks after baseline)
measure: 3-Month Health-Related Quality of Life
timeFrame: 3 Months Post-Surgery (approximately 5 months after baseline)
measure: 1-Year Health-Related Quality of Life
timeFrame: 1 Year Post-Surgery (approximately 14 months after baseline)
measure: Baseline Frailty
timeFrame: baseline assessment - Study entry
measure: Preoperative Frailty
timeFrame: Pre-Surgery (approximately 8 weeks after baseline)
measure: 3-Month Frailty
timeFrame: 3 Months Post-Surgery (approximately 5 months after baseline)
measure: 1-Year Frailty
timeFrame: 1 Year Post-Surgery (approximately 14 months after baseline)
measure: Baseline Anxiety
timeFrame: Baseline Assessment - Study entry
measure: Preoperative Anxiety
timeFrame: Pre-Surgery Assessment (approximately 8 weeks after baseline)
measure: 3-Month Anxiety
timeFrame: 3 Months Post-Surgery (approximately 5 months after baseline)
measure: 1-Year Anxiety
timeFrame: 1 Year Post-Surgery (approximately 14 months after baseline)
measure: Baseline Depression
timeFrame: Baseline Assessment - Study entry
measure: Preoperative Depression
timeFrame: Pre-surgery Assessment ( 8 weeks after baseline)
measure: 3-Month Depression
timeFrame: 3 Months Post-Surgery (approximately 5 months after baseline)
measure: 1 Year Depression
timeFrame: 1 year Post-Surgery (approximately 14 months after baseline)
measure: Postoperative Major Adverse Events
timeFrame: Post-Surgery (approximately 9 weeks after baseline)
measure: Postoperative Cardiac Rehabilitation Attendance
timeFrame: Post-Surgery (approximately 20 weeks after baseline)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital - New Brunswick Heart Centre
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec City
country: Canada
facility: Laval University
state: Quebec
Study officials:
affiliation: St. Boniface Hospital/University of Manitoba
name: Rakesh Arora, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kehler DS, Stammers AN, Tangri N, Hiebert B, Fransoo R, Schultz ASH, Macdonald K, Giacomontonio N, Hassan A, Legare JF, Arora RC, Duhamel TA. Systematic review of preoperative physical activity and its impact on postcardiac surgical outcomes. BMJ Open. 2017 Aug 11;7(8):e015712. doi: 10.1136/bmjopen-2016-015712.
citation: Stammers AN, Kehler DS, Afilalo J, Avery LJ, Bagshaw SM, Grocott HP, Legare JF, Logsetty S, Metge C, Nguyen T, Rockwood K, Sareen J, Sawatzky JA, Tangri N, Giacomantonio N, Hassan A, Duhamel TA, Arora RC. Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial. BMJ Open. 2015 Mar 9;5(3):e007250. doi: 10.1136/bmjopen-2014-007250.