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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patients Waiting for Elective Isolated Coronary Artery Bypass Grafting (CABG), Patients Waiting for Aortic Valve Repair/Replacement for Moderate Aortic Stenosis or Severe Regurgitation, Patients Waiting for Mitral Valve Repair/Replacement for Moderate Stenosis or Severe Regurgitation, Patients Waiting for Combined Procedures. (CAGB and Valve)

Intervention / Treatment
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* Behavioral: Prehab Intervention


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise). | |
| Experimental: Prehab Intervention<br>Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. 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. 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. | Behavioral: Prehab Intervention<br>* Pre-operative, structured exercise intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. | Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days | Post-surgery (approximately 9 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Exercise Capacity | This measure will be assessed using the results of a 6 minute walk test. | baseline assessment - Study entry | 
| Preoperative Exercise Capacity | This measure will be assessed using the results of a 6 minute walk test. | Pre-Surgery (approximately 8 weeks after baseline) | 
| 3-Month Exercise Capacity | This measure will be assessed using the results of a 6 minute walk test. | 3 Months Post-Surgery (approximately 5 months after baseline) | 
| 1-Year Exercise Capacity | This measure will be assessed using the results of a 6 minute walk test. | 1 Year Post-Surgery (approximately 14 months after baseline) | 
| Baseline Physical Activity Behaviour | This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared | baseline assessment - Study entry | 
| Preoperative Physical Activity Behaviour | This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared | Pre-Surgery (approximately 8 weeks after baseline) | 
| 3-Month Physical Activity Behaviour | This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared | 3 Months Post-Surgery (approximately 5 months after baseline) | 
| 1-Year Physical Activity Behaviour | This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared | 1 Year Post-Surgery (approximately 14 months after baseline) | 
| Baseline Health-Related Quality of Life | This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health | baseline assessment - Study entry | 
| Preoperatve Health-Related Quality of Life | This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health | Pre-Surgery (approximately 8 weeks after baseline) | 
| 3-Month Health-Related Quality of Life | This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health | 3 Months Post-Surgery (approximately 5 months after baseline) | 
| 1-Year Health-Related Quality of Life | This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health | 1 Year Post-Surgery (approximately 14 months after baseline) | 
| Baseline Frailty | This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail | baseline assessment - Study entry | 
| Preoperative Frailty | This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail | Pre-Surgery (approximately 8 weeks after baseline) | 
| 3-Month Frailty | This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail | 3 Months Post-Surgery (approximately 5 months after baseline) | 
| 1-Year Frailty | This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail | 1 Year Post-Surgery (approximately 14 months after baseline) | 
| Baseline Anxiety | This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed | Baseline Assessment - Study entry | 
| Preoperative Anxiety | This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed | Pre-Surgery Assessment (approximately 8 weeks after baseline) | 
| 3-Month Anxiety | This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed | 3 Months Post-Surgery (approximately 5 months after baseline) | 
| 1-Year Anxiety | This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed | 1 Year Post-Surgery (approximately 14 months after baseline) | 
| Baseline Depression | This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression | Baseline Assessment - Study entry | 
| Preoperative Depression | This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression | Pre-surgery Assessment ( 8 weeks after baseline) | 
| 3-Month Depression | This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression | 3 Months Post-Surgery (approximately 5 months after baseline) | 
| 1 Year Depression | This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression | 1 year Post-Surgery (approximately 14 months after baseline) | 
| Postoperative Major Adverse Events | Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis. | Post-Surgery (approximately 9 weeks after baseline) | 
| Postoperative Cardiac Rehabilitation Attendance | Will be assessed using administrative data from participating cardiac rehabilitation facilities. | Post-Surgery (approximately 20 weeks after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Care, Exercise Therapy, Cardiac Surgery, Frailty