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 (The EMPOWER Trial): study protocol for a randomised controlled trial

Table 1 Outcomes and assessment measures used in the EMPOWER trial

Outcomes	Assessment measure	Pre CRT	Mid chemo-CRT	Mid CRT	Week 0	Week 3	Week 6	Week 9	Day 3 post-surgery	Day 5 post-surgery	Day 8 post-surgery	Day 15 post-surgery	6 Weeks post-surgery
Primary endpoint
Oxygen uptake at lactate threshold	CPET	X	UHS only		X	X	X	X
Secondary endpoint
Health-related quality of life	Questionnaires: EORTC QLQ-30, EQ-5D	X	UHS only	X	X	X	X	X					X
	Semi-structured interviews				X			X
Physical activity	SenseWear accelerometer	X	UHS only	X	X	X	X	X
Exploratory endpoint
Post-operative morbidity	POMS								X	X	X	X
Cancer staging	MR pelvis mrTRG	X						X
Cancer staging	MR pelvis mrTRG	X						X

Abbreviations: CRT chemoradiotherapy, CPET cardiopulmonary exercise test, UHS University Hospital Southampton, POMS Post- operative morbidity score, mrTRG magnetic resonance tumour regression grade, MR magnetic resonance

ISSN: 1745-6215