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)

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

BACKGROUND: 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. 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. METHODS: Between 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 (VO(2) at AT (ml kg(−1) min(−1))) between groups were compared using linear mixed modelling. RESULTS: Thirty-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 VO(2) 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. CONCLUSION: A 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 REGISTRATION: ClinicalTrials.gov NCT01914068. Registered 1 August 2013. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13741-021-00190-8.