PREPARE trial: a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores

Daniel I McIsaac, Dean A Fergusson, Rachel Khadaroo, Amanda Meliambro, John Muscedere, Chelsia Gillis, Emily Hladkowicz, Monica Taljaard, PREPARE Investigators, Keely Barnes, Sylvain Boet, Laura Boland, Karina Branje, Rodney Breau, Gregory L Bryson, Rosaleen Chun, Irfan Dhalla, Gary Dobson, Elijah Dixon, Antoine Eskander, Alan Forster, Hannah Frazer, Sylvain Gagne, Jayna Holroyd-Leduc, Allen Huang, Joanne Hutton, Eric Jacobsohn, John Joanisse, Ana Johnson, Stephanie Johnson, Manoj M Lalu, Luke T Lavallee, Tien Le, Susan Lee, Cameron Love, Grace Ma, Colin McCartney, Michael McMullen, Husein Moloo, Ronald Moore, Thomas Mutter, Sudhir Nagpal, Julie Nantel, Gregg Nelson, Barbara Power, Tarit Saha, Celena Scheede-Bergdhal, Pablo Serrano, Laura Tamblyn-Watts, Kednapa Thavorn, Daniel Trottier, Carl van Walraven, Brittany Warren, Duminda Wijeysundera, Ilun Yang, Daniel I McIsaac, Dean A Fergusson, Rachel Khadaroo, Amanda Meliambro, John Muscedere, Chelsia Gillis, Emily Hladkowicz, Monica Taljaard, PREPARE Investigators, Keely Barnes, Sylvain Boet, Laura Boland, Karina Branje, Rodney Breau, Gregory L Bryson, Rosaleen Chun, Irfan Dhalla, Gary Dobson, Elijah Dixon, Antoine Eskander, Alan Forster, Hannah Frazer, Sylvain Gagne, Jayna Holroyd-Leduc, Allen Huang, Joanne Hutton, Eric Jacobsohn, John Joanisse, Ana Johnson, Stephanie Johnson, Manoj M Lalu, Luke T Lavallee, Tien Le, Susan Lee, Cameron Love, Grace Ma, Colin McCartney, Michael McMullen, Husein Moloo, Ronald Moore, Thomas Mutter, Sudhir Nagpal, Julie Nantel, Gregg Nelson, Barbara Power, Tarit Saha, Celena Scheede-Bergdhal, Pablo Serrano, Laura Tamblyn-Watts, Kednapa Thavorn, Daniel Trottier, Carl van Walraven, Brittany Warren, Duminda Wijeysundera, Ilun Yang

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.

Keywords: clinical trials; geriatric medicine; surgery.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow. CFS, Clinical Frailty Scale; CNST, Canadian Nutrition Screening Tool; DASI, Duke Activity Status Index; eLOS, expected length of stay; PHQ2-Personal Health Questionnaire; POMS, Postoperative Morbidity Survey; 5TSTS, 5 Times Sit to Stand; TDF, Theoretical Domains Framework; WHODAS, WHO Disability Assessment Schedule.

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