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)

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