The effect of a pre- and post-operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial

Table 1 Timeline of assessments in the PERIOP-OG trial

Outcomes	Assessment measure	Baseline	Post NCT	Pre-op	Day 3 post-op	Day 5 post-op	4 weeks post-op	10 weeks post -op
Primary Endpoint- Cardiorespiratory fitness	6 MWT	X	X	X			X	X
Secondary Endpoints
Physical Health-Strength	Sit to stand test Grip strength	X	X	X			X	X
Activity Behaviours	Accelerometer	X	X	X			X	X
Body Composition	BMI	X	X	X			X	X
Psychological Health-Optimism	LOT-R	X
HRQoL	EQ-5D/FACT-E/ GSE/PMS	X	X	X			X	X
HRQoL	Semi-structured interview			X			X
Surgical Fear As measured by SFQ Time points Baseline post NCT Pre Surgery
Exploratory Endpoints
Clinical Health- Nutrition	GPS	X	X	X	X	X	X
	Sarcopenia score	X	X	X			X
	Foodbook 24	X	X	X			X	X
Morbidity	POMS				X	X
	CD Classification						X
Inflammatory Markers	WCC, CRP	X	X	X	X	X

Abbreviations: NCT neoadjuvant chemotherapy, 6 MWT 6-min walk test, BMI body mass index, LOT-R Life Orientation Test-Revised, HR QoL Health realted quality of life, FACT-E Functional Assessment of Cancer Therapy-Esophageal, GSE General Self-Efficacy, PMS Pearlin Mastery Scale, SFQ Surgical fear questionnaire, GPS Glasgow Prognostic Score, POMS Post-Operative Morbidity Score, CD Clavien-Dindo Classification, WCC white cell count, CRP C-Reactive Protein

ISSN: 1745-6215