The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER Trial)

Lisa Loughney,Shaunna Burke,Lesley Hawkins,Sandy Jack,Daniel H Palmer,Michael P W Grocott,Michael G Mythen,Judit Varkonyi-Sepp,Christopher P Barben,Peter M Calverley,Graham J Kemp,Helen Moyses,On Behalf Of The Fit4Surgery Group ,Malcolm A West,Trevor Cox,Andrew Bates

doi:10.1186/s13741-021-00190-8

Abstract

BackgroundThe EMPOWER trial aimed to assess the effects of a 9-week exercise prehabilitation programme on physical fitness compared with a usual care control group. Secondary aims were to investigate the effect of (1) the exercise prehabilitation programme on psychological health; and (2) neoadjuvant chemoradiotherapy (NCRT) on physical fitness and psychological health.MethodsBetween October 2013 and December 2016, adults with locally advanced rectal cancer undergoing standardised NCRT and surgery were recruited to a multi-centre trial. Patients underwent cardiopulmonary exercise testing (CPET) and completed HRQoL questionnaires (EORTC-QLQ-C30 and EQ-5D-5L) pre-NCRT and post-NCRT (week 0/baseline). At week 0, patients were randomised to exercise prehabilitation or usual care (no intervention). CPET and HRQoL questionnaires were assessed at week 0, 3, 6 and 9, whilst semi-structured interviews were assessed at week 0 and week 9. Changes in oxygen uptake at anaerobic threshold (VO2 at AT (ml kg−1 min−1)) between groups were compared using linear mixed modelling.ResultsThirty-eight patients were recruited, mean age 64 (10.4) years. Of the 38 patients, 33 were randomised: 16 to usual care and 17 to exercise prehabilitation (26 males and 7 females). Exercise prehabilitation significantly improved VO2 at AT at week 9 compared to the usual care. The change from baseline to week 9, when adjusted for baseline, between the randomised groups was + 2.9 ml kg −1 min −1; (95% CI 0.8 to 5.1), p = 0.011.ConclusionA 9-week exercise prehabilitation programme significantly improved fitness following NCRT. These findings have informed the WesFit trial (NCT03509428) which is investigating the effects of community-based multimodal prehabilitation before cancer surgery.Trial registrationClinicalTrials.gov NCT01914068. Registered 1 August 2013.

Highlights

The EMPOWER trial aimed to assess the effects of a 9-week exercise prehabilitation programme on physical fitness compared with a usual care control group
Exercise prehabilitation significantly improved Oxygen uptake (VO2) at Anaerobic threshold (AT) at week 9 compared to the usual care
The standard waiting period between completion of neoadjuvant chemoradiotherapy (NCRT) and surgery is generally at least 8 weeks (Du et al 2017) (or in some National Health Service (NHS) hospitals up to 14 weeks) and represents a unique opportunity to intervene with exercise prehabilitation

Summary

Introduction

The EMPOWER trial aimed to assess the effects of a 9-week exercise prehabilitation programme on physical fitness compared with a usual care control group. The standard waiting period between completion of NCRT and surgery is generally at least 8 weeks (Du et al 2017) (or in some National Health Service (NHS) hospitals up to 14 weeks) and represents a unique opportunity to intervene with exercise prehabilitation In this area of research, early evidence demonstrates the feasibility and preliminary effectiveness of exercise training (unimodal prehabilitation delivered in varied formats) for people with rectal cancer scheduled for NCRT and surgery (Heldens et al 2016; Morielli et al 2016a; Morielli et al 2016b; Morielli et al 2018a; Moug et al 2019; Singh et al 2018; West et al 2014b). No exercise RCTs have been reported on both physical and psychological health measures in people with rectal cancer ( the EXERT trial is currently recruiting) (Morielli et al 2018b) or any patient group scheduled for a multimodal treatment pathway (Loughney et al 2018)

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