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

PREPARE-ABC Trial Collaborative, James Hernon, John M. Saxton, Megan Jones, Gregory Howard, Ann Marie Swart, Allan Clark, Susan Stirling, David Turner, Jamie Murdoch, Jurgens Nortje, Simon Bach, Nicola Fearnhead, Farhat Din, Alan Stephens, Jonathan Lund, Samson Tou, Seamus Kelly, Paul Ziprin, Robert DennisNeil Smart, Campbell Roxburgh, Alastair Simpson, Ami Mishra, Katrina Knight, Kerry Dresser, Anna Wordley, Laura Thomas, Martin Pond, Anthony Colles, Claire West, Katharine Goodall, Ruth Kirk, Glenn Harden, Kerry Dresser, Anna Varley, Jane McCulloch, Jenni Naisby, Katherine Baker

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Abstract

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.

Original languageEnglish
Pages (from-to)2750-2760
Number of pages11
JournalColorectal Disease
Volume23
Issue number10
Early online date2 Sept 2021
DOIs
Publication statusPublished - 1 Oct 2021

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