SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery trial (PREPARE‐ABC): Study protocol for a multicentre randomized controlled trial

Background Exercise programmes can increase cardiopulmonary reserve and functional capacity prior to surgery and can improve clinical, functional and survival outcomes after a colorectal cancer diagnosis. However, the impact of pre‐ and postoperative exercise on postoperative recovery outcomes and l...

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Bibliographic Details
Published in:	Colorectal disease Vol. 23; no. 10; pp. 2750 - 2760
Main Authors:	Hernon, James, Saxton, John M., Jones, Megan, Howard, Gregory, Swart, Ann Marie, Clark, Allan, Stirling, Susan, Turner, David, Murdoch, Jamie, Nortje, Jurgens, Bach, Simon, Fearnhead, Nicola, Din, Farhat, Stephens, Alan, Lund, Jonathan, Tou, Samson, Kelly, Seamus, Ziprin, Paul, Dennis, Robert, Smart, Neil, Roxburgh, Campbell, Simpson, Alastair, Mishra, Ami, Knight, Katrina, Dresser, Kerry, Wordley, Anna, Thomas, Laura, Pond, Martin, Colles, Anthony, West, Claire, Goodall, Katharine, Kirk, Ruth, Harden, Glenn, Varley, Anna, McCulloch, Jane, Naisby, Jenni, Baker, Katherine
Format:	Journal Article
Language:	English
Published:	Chichester Wiley Subscription Services, Inc 01-10-2021
Subjects:	Cancer Cancer surgery Clinical trials Colorectal cancer Colorectal carcinoma Exercise exercise prehabilitation Gastric cancer health‐related quality of life Morbidity Patients Physical activity Physical fitness Physical training postoperative recovery Quality of life Surgery Surgical outcomes
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Summary:	Background Exercise programmes can increase cardiopulmonary reserve and functional capacity prior to surgery and can improve clinical, functional and survival outcomes after a colorectal cancer diagnosis. However, the impact of pre‐ and postoperative exercise on postoperative recovery outcomes and longer‐term health‐related quality of life are unknown; thus, there is a need for high‐quality randomized controlled trials. Method SupPoRtive Exercise Programmes for Accelerating REcovery after major Abdominal Cancer surgery (PREPARE‐ABC) is a three‐arm multicentre randomized controlled trial with internal pilot. The primary objective is to assess the effects of pre‐ and postoperative exercise on surgical outcomes and longer‐term health‐related quality of life in cancer patients undergoing colorectal resection. The aim of PREPARE‐ABC is to randomize 1146 patients at the individual level (1:1:1) to hospital‐supervised exercise, home‐supported exercise or treatment as usual. The primary outcomes are short‐term (30‐day) morbidity, assessed using the Clavien–Dindo classification, and longer‐term health‐related quality of life, assessed using the Medical Outcomes Study Health Questionnaire (36‐item Short‐Form Survey [SF‐36]). Secondary outcomes include cardiopulmonary fitness, physical activity behaviour change, psychological health status and cost‐effectiveness. A process evaluation of intervention delivery and usual care also will be undertaken. Discussion This is the first UK‐based definitive randomized controlled trial to investigate the effects of pre‐ and postoperative exercise on short‐term postoperative health outcomes and longer‐term health‐related quality of life in colorectal cancer patients. The trial will yield robust clinical and cost‐effectiveness data to underpin clinical guidance on how exercise programmes should be implemented in the routine management of patients undergoing major colorectal cancer surgery.
Bibliography:	1 Trial registration: ISRCTN82233115 Funding Information Collaborating members are listed in Appendix Trial Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust. Sponsor's reference: 200804 (NNUH, Norwich Research Park, Norwich NR4 7UY, UK). The PREPARE‐ABC trial is fully funded by National Institute for Health Research Health Technology Assessment Programme; Grant Number 14/192/53. ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	1462-8910 1463-1318
DOI:	10.1111/codi.15805