BMJ Open (Aug 2022)
PREPARE trial: a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores
- Dean A Fergusson,
- Alan Forster,
- Gregg Nelson,
- Monica Taljaard,
- Jayna Holroyd-Leduc,
- Manoj M Lalu,
- John Muscedere,
- Duminda Wijeysundera,
- Daniel I McIsaac,
- Sylvain Boet,
- Kednapa Thavorn,
- Michael McMullen,
- Tarit Saha,
- Eric Jacobsohn,
- Tien Le,
- Husein Moloo,
- Allen Huang,
- Gary Dobson,
- Grace Ma,
- Stephanie Johnson,
- Colin McCartney,
- Elijah Dixon,
- Emily Hladkowicz,
- Sylvain Gagne,
- Julie Nantel,
- Barbara Power,
- Chelsia Gillis,
- Rodney Breau,
- Irfan Dhalla,
- Susan Lee,
- Rachel Khadaroo,
- Amanda Meliambro,
- Daniel Trottier,
- Keely Barnes,
- Laura Boland,
- Karina Branje,
- Gregory L. Bryson,
- Rosaleen Chun,
- Antoine Eskander,
- Hannah Frazer,
- Joanne Hutton,
- John Joanisse,
- Ana Johnson,
- Luke T. Lavallee,
- Cameron Love,
- Ronald Moore,
- Thomas Mutter,
- Sudhir Nagpal,
- Celena Scheede-Bergdhal,
- Pablo Serrano,
- Laura Tamblyn-Watts,
- Carl van Walraven,
- Brittany Warren,
- Ilun Yang
Affiliations
- Dean A Fergusson
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Alan Forster
- 2 Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Toronto, Ontario, Canada
- Gregg Nelson
- 6 Department of Obstetrics & Gynecology, University of Calgary, Calgary, Alberta, Canada
- Monica Taljaard
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Jayna Holroyd-Leduc
- Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
- Manoj M Lalu
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- John Muscedere
- Canadian Frailty Network, Kingston, Ontario, Canada
- Duminda Wijeysundera
- 7Department of Anesthesia, University Health Network-Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada
- Daniel I McIsaac
- Anesthesiology and Pain Medicine, Ottawa Hospital Research Institute Clinical Epidemiology Program, Ottawa, Ontario, Canada
- Sylvain Boet
- Department of Anesthesiology and Pain Medicine, University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada
- Kednapa Thavorn
- Institute for Clinical Evaluative Sciences, Ottawa, Ontario, Canada
- Michael McMullen
- 1 Department of Anesthesiology and Perioperative Medicine, Queen’s University, Kingston, Ontario, Canada
- Tarit Saha
- 5 Anesthesiology and Perioperative Medicine, Kingston General Hospital, Kingston, Ontario, Canada
- Eric Jacobsohn
- 9 Rady Faculty of Health Sciences and Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
- Tien Le
- 3 The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Husein Moloo
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Allen Huang
- 3 Geriatric Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada
- Gary Dobson
- Grace Ma
- 1Health Sciences North/Horizon Sante Nord, Sudbury, ON, Canada
- Stephanie Johnson
- 1Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, University of Sydney, Sydney, New South Wales, Australia
- Colin McCartney
- 14 Department of Anesthesiology, The Ottawa Hospital, Ottawa, Ontario, Canada
- Elijah Dixon
- 1Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada
- Emily Hladkowicz
- Anesthesiology and Pain Medicine, Ottawa Hospital Research Institute Clinical Epidemiology Program, Ottawa, Ontario, Canada
- Sylvain Gagne
- 1 Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada
- Julie Nantel
- 9 School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Canada
- Barbara Power
- 5 Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Chelsia Gillis
- School of Human Nutrition, McGill University, Montreal, Quebec, Canada
- Rodney Breau
- Irfan Dhalla
- associate professor
- Susan Lee
- Institute of Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), Faculty of Human Sciences and Faculty of Medicine, University of Cologne, Cologne, Germany
- Rachel Khadaroo
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada
- Amanda Meliambro
- Patient Engagement, Ottawa Hospital General Campus, Ottawa, Ontario, Canada
- Daniel Trottier
- surgeon
- Keely Barnes
- Laura Boland
- Karina Branje
- Gregory L. Bryson
- Rosaleen Chun
- Antoine Eskander
- Hannah Frazer
- Joanne Hutton
- John Joanisse
- Ana Johnson
- Luke T. Lavallee
- Cameron Love
- Ronald Moore
- Thomas Mutter
- Sudhir Nagpal
- Celena Scheede-Bergdhal
- Pablo Serrano
- Laura Tamblyn-Watts
- Carl van Walraven
- Brittany Warren
- Ilun Yang
- DOI
- https://doi.org/10.1136/bmjopen-2022-064165
- Journal volume & issue
-
Vol. 12,
no. 8
Abstract
Introduction Frailty is a strong predictor of adverse postoperative outcomes. Prehabilitation may improve outcomes after surgery for older people with frailty by addressing physical and physiologic deficits. The objective of this trial is to evaluate the efficacy of home-based multimodal prehabilitation in decreasing patient-reported disability and postoperative complications in older people with frailty having major surgery.Methods and analysis We will conduct a multicentre, randomised controlled trial of home-based prehabilitation versus standard care among consenting patients >60 years with frailty (Clinical Frailty Scale>4) having elective inpatient major non-cardiac, non-neurologic or non-orthopaedic surgery. Patients will be partially blinded; clinicians and outcome assessors will be fully blinded. The intervention consists of >3 weeks of prehabilitation (exercise (strength, aerobic and stretching) and nutrition (advice and protein supplementation)). The study has two primary outcomes: in-hospital complications and patient-reported disability 30 days after surgery. Secondary outcomes include survival, lower limb function, quality of life and resource utilisation. A sample size of 750 participants (375 per arm) provides >90% power to detect a minimally important absolute difference of 8 on the 100-point patient-reported disability scale and a 25% relative risk reduction in complications, using a two-sided alpha value of 0.025 to account for the two primary outcomes. Analyses will follow intention to treat principles for all randomised participants. All participants will be followed to either death or up to 1 year.Ethics and dissemination Ethical approval has been granted by Clinical Trials Ontario (Project ID: 1785) and our ethics review board (Protocol Approval #20190409-01T). Results will be disseminated through presentation at scientific conferences, through peer-reviewed publication, stakeholder organisations and engagement of social and traditional media.Trial registration number NCT04221295.
