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

Patients Waiting for Aortic Valve Repair/Replacement for Moderate Aortic Stenosis or Severe Regurgitation Clinical Trial

— PREHAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219815
• Other study ID #: PREHAB
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: October 2021
• Source: St. Boniface Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Prehab Intervention
Pre-operative, structured exercise intervention.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Laval University	Quebec City	Quebec
Canada	Saint John Regional Hospital - New Brunswick Heart Centre	Saint John	New Brunswick
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
St. Boniface Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline Exercise Capacity	This measure will be assessed using the results of a 6 minute walk test.	baseline assessment - Study entry
Secondary	Preoperative Exercise Capacity	This measure will be assessed using the results of a 6 minute walk test.	Pre-Surgery (approximately 8 weeks after baseline)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Postoperative Cardiac Rehabilitation Attendance	Will be assessed using administrative data from participating cardiac rehabilitation facilities.	Post-Surgery (approximately 20 weeks after baseline)