TY - JOUR
T1 - SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery trial (PREPARE-ABC)
T2 - study protocol for a multicentre randomized controlled trial
AU - the PREPARE-ABC Trial Collaborative
AU - Hernon, James
AU - Saxton, John M.
AU - Jones, Megan
AU - Howard, Gregory
AU - Swart, Ann Marie
AU - Clark, Allan
AU - Stirling, Susan
AU - Turner, David
AU - Murdoch, Jamie
AU - Nortje, Jurgens
AU - Bach, Simon
AU - Fearnhead, Nicola
AU - Din, Farhat
AU - Stephens, Alan
AU - Lund, Jonathan
AU - Tou, Samson
AU - Kelly, Seamus
AU - Ziprin, Paul
AU - Dennis, Robert
AU - Smart, Neil
AU - Roxburgh, Campbell
AU - Simpson, Alastair
AU - Mishra, Ami
AU - Knight, Katrina
AU - Wordley, Anna
AU - Thomas, Laura
AU - Pond, Martin
AU - Colles, Anthony
AU - West, Claire
AU - Goodall, Katharine
AU - Kirk, Ruth
AU - Harden, Glenn
AU - Dresser, Kerry
AU - Varley, Anna
AU - McCulloch, Jane
AU - Naisby, Jenni
AU - Baker, Katherine
N1 - Funding Information:
The PREPARE‐ABC trial is fully funded by National Institute for Health Research Health Technology Assessment Programme; Grant Number 14/192/53.
Publisher Copyright:
© 2021 The Association of Coloproctology of Great Britain and Ireland
PY - 2021/10
Y1 - 2021/10
N2 - 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.
AB - 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.
KW - colorectal cancer
KW - exercise prehabilitation
KW - health-related quality of life
KW - postoperative recovery
UR - http://www.scopus.com/inward/record.url?scp=85114496407&partnerID=8YFLogxK
U2 - 10.1111/codi.15805
DO - 10.1111/codi.15805
M3 - Article
C2 - 34245094
AN - SCOPUS:85114496407
SN - 1462-8910
VL - 23
SP - 2750
EP - 2760
JO - Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland
JF - Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland
IS - 10
ER -
