Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol

INTRODUCTION: Prehabilitation interventions have shown efficacy in the orthopaedic and cardiothoracic surgical populations, but there has been limited evidence for general surgical patients. We present the protocol for a pilot trial of a novel prehabilitation intervention, consisting of a physiatrist-directed preoperative assessment and treatment programme. METHODS AND ANALYSIS: This is a single-centre pilot randomised controlled trial investigating physiatrist-directed prehabilitation for a 4 to 6-week preoperative period. We will block randomise 40-50 participants awaiting surgery for colorectal cancer to prehabilitation versus control. Participants in the prehabilitation arm will undergo assessment by a physiatrist and enrol in a supervised exercise programme. The control group will not undergo any prehabilitation interventions in the preoperative period. Our primary outcome is feasibility, measured by examining recruitment, refusal, retention and adherence rates as well as participant satisfaction and feedback. Secondary outcomes include physical fitness, functional ability, health-related quality of life, postoperative complications, mortality, readmissions, length of stay, prehabilitation interventions performed and exercise complications. ETHICS AND DISSEMINATION: This study has been approved by the Hamilton Integrated Research Ethics Board (HIREB reference number 2015-0090-GRA). The results of this pilot study will be used to design a full-scale study and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02531620; Pre-results.