PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery

Daniel I McIsaac, Chelsey Saunders, Emily Hladkowicz, Gregory L Bryson, Alan J Forster, Sylvain Gagne, Allen Huang, Manoj Lalu, Luke T Lavallee, Husein Moloo, Julie Nantel, Barbara Power, Celena Scheede-Bergdahl, Monica Taljaard, Carl van Walraven, Colin J L McCartney, Daniel I McIsaac, Chelsey Saunders, Emily Hladkowicz, Gregory L Bryson, Alan J Forster, Sylvain Gagne, Allen Huang, Manoj Lalu, Luke T Lavallee, Husein Moloo, Julie Nantel, Barbara Power, Celena Scheede-Bergdahl, Monica Taljaard, Carl van Walraven, Colin J L McCartney

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.

Keywords: exercise; frailty; functional outcomes; geriatrics; surgery.

Conflict of interest statement

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.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study flow. BPNES, Basic Psychological Needs in Exercise Scale; CFS, Clinical Frailty Scale; 6-MWT, 6 min walk test; PANAS, Positive and Negative Affect Schedule; SPPB, short physical performance battery; TDF, Theoretical Domains Framework; WHODAS, WHO Disability Assessment Schedule measuring Disability-Free Survival; EQ-5D: Health-Related Quality of Life Measure; Baseline Activity Questionnaire; Fear of Falling Questionnaire; Healthcare resource utilisation: length of hospital stay, discharge to an institution, readmissions within 30 days of discharge and total healthcare costs.

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