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Protocol for the PREHAB study—Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial
  1. Andrew N Stammers1,2,
  2. D Scott Kehler1,2,
  3. Jonathan Afilalo3,
  4. Lorraine J Avery4,
  5. Sean M Bagshaw5,
  6. Hilary P Grocott6,7,
  7. Jean-Francois Légaré8,
  8. Sarvesh Logsetty6,
  9. Colleen Metge4,9,
  10. Thang Nguyen10,
  11. Kenneth Rockwood11,
  12. Jitender Sareen9,12,
  13. Jo-Ann Sawatzky2,13,
  14. Navdeep Tangri14,
  15. Nicholas Giacomantonio15,
  16. Ansar Hassan16,
  17. Todd A Duhamel1,2,17,
  18. Rakesh C Arora2,6
  1. 1Faculty of Kinesiology & Recreation Management, Health, Leisure & Human Performance Research Institute, University of Manitoba, Winnipeg, Manitoba, Canada
  2. 2Institute of Cardiovascular Sciences, St. Boniface Hospital Research Centre, Winnipeg, Manitoba, Canada
  3. 3Divisions of Cardiology and Clinical Epidemiology, Department of Medicine, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
  4. 4Winnipeg Regional Health Authority Cardiac Sciences Program, Winnipeg, Manitoba, Canada
  5. 5Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada
  6. 6Department of Surgery, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
  7. 7Department of Anesthesia & Perioperative Medicine, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
  8. 8Division of Cardiac Surgery, Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada
  9. 9Department of Community Health Sciences, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
  10. 10Section of Cardiology, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
  11. 11Division of Geriatric Medicine, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
  12. 12Department of Psychiatry, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
  13. 13Faculty of Health Sciences, College of Nursing, University of Manitoba, Winnipeg, Manitoba, Canada
  14. 14Section of Nephrology, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
  15. 15Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
  16. 16Department of Cardiac Surgery, New Brunswick Heart Centre, Saint John Regional Hospital, Saint John, New Brunswick, Canada
  17. 17Department of Physiology, University of Manitoba, Winnipeg, Manitoba, Canada
  1. Correspondence to Dr Rakesh C Arora; rarora{at}sbgh.mb.ca

Abstract

Introduction Frailty is a geriatric syndrome characterised by reductions in muscle mass, strength, endurance and activity level. The frailty syndrome, prevalent in 25–50% of patients undergoing cardiac surgery, is associated with increased rates of mortality and major morbidity as well as function decline postoperatively. This trial will compare a preoperative, interdisciplinary exercise and health promotion intervention to current standard of care (StanC) for elective coronary artery bypass and valvular surgery patients for the purpose of determining if the intervention improves 3-month and 12-month clinical outcomes among a population of frail patients waiting for elective cardiac surgery.

Methods and analysis This is a multicentre, randomised, open end point, controlled trial using assessor blinding and intent-to-treat analysis. Two-hundred and forty-four elective cardiac surgical patients will be recruited and randomised to receive either StanC or StanC plus an 8-week exercise and education intervention at a certified medical fitness facility. Patients will attend two weekly sessions and aerobic exercise will be prescribed at 40–60% of heart rate reserve. Data collection will occur at baseline, 1–2 weeks preoperatively, and at 3 and 12 months postoperatively. The primary outcome of the trial will be the proportion of patients requiring a hospital length of stay greater than 7 days.

Potential impact of study The healthcare team is faced with an increasingly complex older adult patient population. As such, this trial aims to provide novel evidence supporting a health intervention to ensure that frail, older adult patients thrive after undergoing cardiac surgery.

Ethics and dissemination Trial results will be published in peer-reviewed journals, and presented at national and international scientific meetings. The University of Manitoba Health Research Ethics Board has approved the study protocol V.1.3, dated 11 August 2014 (H2014:208).

Trial registration number The trial has been registered on ClinicalTrials.gov, a registry and results database of privately and publicly funded clinical studies (NCT02219815).

  • PREVENTIVE MEDICINE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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