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

NCT02219815 | Completed Results DMC

• 1 other identifier: PREHAB
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Baseline Exercise Capacity

  baseline assessment - Study entry

• Preoperative Exercise Capacity

  Pre-Surgery (approximately 8 weeks after baseline)

• 3-Month Exercise Capacity

  3 Months Post-Surgery (approximately 5 months after baseline)

• 1-Year Exercise Capacity

  1 Year Post-Surgery (approximately 14 months after baseline)

• Baseline Physical Activity Behaviour

  baseline assessment - Study entry

Study Arms (2)

Standard Care

NO INTERVENTION

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).

Prehab Intervention

EXPERIMENTAL

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

Interventions

Prehab Intervention BEHAVIORAL

Pre-operative, structured exercise intervention.

Prehab Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Boniface Hospital: lead

Study Sites (5)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H2A6, Canada

Location

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, New Brunswick, E2L4L2, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H3A7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Laval University

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (2)

• 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.

  PMID: 28801404 DERIVED

• 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.

  PMID: 25753362 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. Recruitment was only 89 participants from an expected sample size of 244 participants. This was a major limitation regarding data analysis. 2. Short cardiac surgery waitlists (i.e. surgery in less than 4 weeks) were impactful to study recruitment and intervention delivery

Results Point of Contact

• Title: Dr. Rakesh Arora
• Organization: St. Boniface Hospital

rarora@sbgh.mb.ca

2042581078

Study Officials

• Rakesh Arora, MD

  St. Boniface Hospital/University of Manitoba

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Intensive Care Cardiac Sciences

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 19, 2014
• Study Start: April 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 29, 2024
• Results First Posted: October 13, 2021

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)