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

Not Applicable

Completed

• 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)
• Interventions: Behavioral: Prehab Intervention

• Registration Number: NCT02219815
• Lead Sponsor: St. Boniface Hospital

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.

Study Timeline

• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-19
• Study Start: 2015-04
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Results First Submitted: 2021-09-15
• Results First Submitted QC: 2021-09-15
• Results First Posted: 2021-10-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehab Intervention	Prehab Intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
3-Month Exercise Capacity	3 Months Post-Surgery (approximately 5 months after baseline)	This measure will be assessed using the results of a 6 minute walk test.
Baseline Exercise Capacity	baseline assessment - Study entry	This measure will be assessed using the results of a 6 minute walk test.
Preoperative Exercise Capacity	Pre-Surgery (approximately 8 weeks after baseline)	This measure will be assessed using the results of a 6 minute walk test.
Preoperative Physical Activity Behaviour	Pre-Surgery (approximately 8 weeks after baseline)	This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Baseline Health-Related Quality of Life	baseline assessment - Study entry	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-Month Health-Related Quality of Life	3 Months Post-Surgery (approximately 5 months after baseline)	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 Frailty	1 Year Post-Surgery (approximately 14 months after baseline)	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 Anxiety	1 Year Post-Surgery (approximately 14 months after baseline)	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 Frailty	baseline assessment - Study entry	This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Preoperative Depression	Pre-surgery Assessment ( 8 weeks after baseline)	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-Month Physical Activity Behaviour	3 Months Post-Surgery (approximately 5 months after baseline)	This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Preoperatve Health-Related Quality of Life	Pre-Surgery (approximately 8 weeks after baseline)	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 Health-Related Quality of Life	1 Year Post-Surgery (approximately 14 months after baseline)	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-Month Frailty	3 Months Post-Surgery (approximately 5 months after baseline)	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 Anxiety	Baseline Assessment - Study entry	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 Depression	1 year Post-Surgery (approximately 14 months after baseline)	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 Exercise Capacity	1 Year Post-Surgery (approximately 14 months after baseline)	This measure will be assessed using the results of a 6 minute walk test.
Preoperative Anxiety	Pre-Surgery Assessment (approximately 8 weeks after baseline)	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
Postoperative Major Adverse Events	Post-Surgery (approximately 9 weeks after baseline)	Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.
Baseline Physical Activity Behaviour	baseline assessment - Study entry	This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
1-Year Physical Activity Behaviour	1 Year Post-Surgery (approximately 14 months after baseline)	This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Preoperative Frailty	Pre-Surgery (approximately 8 weeks after baseline)	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-Month Anxiety	3 Months Post-Surgery (approximately 5 months after baseline)	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 Depression	Baseline Assessment - Study entry	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-Month Depression	3 Months Post-Surgery (approximately 5 months after baseline)	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
Postoperative Cardiac Rehabilitation Attendance	Post-Surgery (approximately 20 weeks after baseline)	Will be assessed using administrative data from participating cardiac rehabilitation facilities.

Trial Locations

Locations (5)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

Saint John Regional Hospital - New Brunswick Heart Centre; 🇨🇦 Saint John, New Brunswick, Canada

Laval University; 🇨🇦 Quebec City, Quebec, Canada

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada