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PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery
  1. Daniel I McIsaac1,2,
  2. Chelsey Saunders3,
  3. Emily Hladkowicz3,
  4. Gregory L Bryson1,2,
  5. Alan J Forster4,5,
  6. Sylvain Gagne1,
  7. Allen Huang5,6,
  8. Manoj Lalu1,2,
  9. Luke T Lavallee2,7,
  10. Husein Moloo2,8,
  11. Julie Nantel9,
  12. Barbara Power5,6,
  13. Celena Scheede-Bergdahl10,
  14. Monica Taljaard5,11,
  15. Carl van Walraven5,12,13,
  16. Colin J L McCartney1,14
  1. 1 Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada
  2. 2 Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  3. 3 Department of Anesthesiology and Pain Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  4. 4 Division of General Internal Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada
  5. 5 Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  6. 6 Division of Geriatric Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada
  7. 7 Division of Urology, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada
  8. 8 Division of General Surgery, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada
  9. 9 School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Canada
  10. 10 Department of Kinesiology and Physical Education, McGill University, Montreal, Quebec, Canada
  11. 11 School of Epidemiology, Population Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada
  12. 12 Department of Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada
  13. 13 Institute for Clinical Evaluative Sciences, Ottawa, Ontario, Canada
  14. 14 The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  1. Correspondence to Dr Daniel I McIsaac; dmcisaac{at}toh.ca

Abstract

Introduction Exercise prehabilitation may improve outcomes after surgery. Frailty is a key predictor of adverse postoperative outcomes in older people; the multidimensional nature of frailty makes this a population who may derive substantial benefit from exercise prehabilitation. The objective of this trial is to test the efficacy of exercise prehabilitation to improve postoperative functional outcomes for people living with frailty having cancer surgery with curative intent.

Methods and analysis We will conduct a single-centre, parallel-arm randomised controlled trial of home-based exercise prehabilitation versus standard care among consenting patients >60 years having elective cancer surgery (intra-abdominal and intrathoracic) and who are frail (Clinical Frailty Scale >4). The intervention consists of > 3 weeks of exercise prehabilitation (strength, aerobic and stretching). The primary outcome is the 6 min walk test at the first postoperative clinic visit. Secondary outcomes include the short physical performance battery, health-related quality of life, disability-free survival, complications and health resource utilisation. The primary outcome will be analysed by intention to treat using analysis of covariance. Outcomes up to 1 year after surgery will be ascertained through linkage to administrative data.

Ethics and dissemination Ethical approval has been granted by our ethics review board (Protocol Approval #2016009–01H). 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 NCT02934230; Pre-results.

  • geriatrics
  • exercise
  • functional outcomes
  • frailty
  • surgery

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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Footnotes

  • Contributors DIM is the principal investigator. DIM was involved in the conception and design of the study and initial draft of the protocol. CS contributed to the draft of the protocol. CS and EH participated in the implementation of the study (submissions to ethics committee, daily management of the trial) and EH critically reviewed the protocol and its contents. JN provided her expertise in kinesiology and contributed to the knowledge needed for the prehabilitation program. HM, LTL, ML, GLB, AH and SG provided their experience in epidemiology, quality improvement and clinical practice to the study design and procedures, and writing of the protocol. BP provided her knowledge for the care of ageing patients and provided insight into the intervention design. AJF contributed heavily to the study design and methodology. CS-B contributed to the study design and the details of the intervention and control groups. CvW was involved in the study methodology and provided his expertise on data linkage. MT developed the analysis plan. CJLM provided mentorship oversight and helped draft the protocol. All authors read and approved the final protocol.

  • Funding This work was supported by the International Anesthesia Research Society and the University of Ottawa Anesthesiology Research Grant.

  • Competing interests LTL reports grants from Sanofi, personal fees from Sanofi and Ferring, outside the submitted work. CJLM reports other from Teleflex Medical, outside the submitted work.

  • Patient consent Not required.

  • Ethics approval Prior to the commencement of the study, the protocol was presented to the independent ethics committee of The Ottawa Health Sciences Network—Research Ethics Board. Ethics approval was subsequently granted (Protocol #2 016 0091–01H).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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