A major trial will test whether exercise before and after surgery can reduce complications and improve quality of life for colorectal cancer patients. Around half of patients undergoing curative colorectal cancer surgery develop complications within 30 days, and recovery can be slow. Current standard care offers no structured exercise support. This trial compares two exercise programmes—one supervised in hospital, the other supported at home—against standard care alone, to see whether either approach reduces post-operative morbidity and improves long-term health-related quality of life. If the exercise programmes prove effective, the NHS could adopt a simple, low-cost intervention that helps patients recover faster, spend fewer days in hospital, and return to normal life sooner. The trial also includes a cost-effectiveness analysis, so funders will know whether the benefits justify the expense. Even if only one of the two exercise arms works, the results could reshape peri-operative care for thousands of patients each year.
View original technical description
Design: A Multi-centre randomised controlled trial recruiting cancer patients awaiting curative colorectal cancer surgery from colorectal UK units. Patients will be randomized to: standard care plus pre and post-hospital discharge supervised hospital-based exercise, standard care plus pre and post-hospital discharge supported home-based exercise and standard care alone pre and post-hospital discharge. An internal pilot phase 7-18 months is built into the design to confirm recruitment before progressing to the full study. Setting: Hospital / Community. Target population: NHS patients awaiting a curative elective colorectal resection. Inclusion Criteria: Males and Females 18yrs older with American Society of Anaesthesiologists physical status I-III. Exclusion Criteria: Contraindications to exercise. Health technology being assessed: Pre and post-hospital discharge exercise vs. standard care. Two exercise regimes: supervised hospital-based and supported home-based. Supervised exercise: Pre-operative period - 45 min exercise counseling session followed by a maximum of 12 aerobic interval exercise sessions 3-4 weeks prior to surgery. Post-hospital discharge - monthly supervised "booster" exercise sessions up to 12 months post-randomisation. Supported home-based exercise: Pre-operative period - 45 min exercise counselling session, followed by a home-exercise programme achieving a minimum of 150 min of moderate aerobic exercise per week. Post-hospital discharge - monthly telephone support until 12 months post-randomisation. Twice weekly resistance exercise will be offered to intervention groups. Counselling sessions / patient contact will incorporate behavioural modification methodology. Patients requiring pre-operative chemo-radiotherapy will start exercise post chemo-radiotherapy. Standard care: Other than the patient information leaflet, no other information relating to peri-operative exercise will be offered. Outcomes: Primary: Short term - Post operative morbidity (POM) 30-days measured by the Clavien-Dindo classification. Long term - HR-QoL at 1 year using the Medical Outcomes Study Short-Form Health Questionnaire (SF-36) and EQ-5D-5L. Secondary: Pre operative change in CPET variables following exercise. Post operative: Length of stay, readmission rate, POM at discharge, 90-day post-operative mortality, Psychological Health Status and self-efficacy for exercise. Cost-effectiveness: Health care resource use and QALYs (using EQ-5D-5L and SF36 via SF6D) will be calculated to estimate incremental cost per QALY of exercise compared to standard care. Process Evaluation: To access interventions we will evaluate - Standard care at each unit prior to randomisation, fidelity to intervention and control arms and any contamination across arms and patient’s views and experiences of interventions. Sample size: POM evident in 55% of patients by day 30. To detect a 25% reduction (relative risk 0.75), 90% power, alpha 2.5%, requires 343 in each arm, 3 arms 1029, 10% attrition rate. Total 1146. Average SF 36 score at 1 year is 52 SD 10. To detect a 3 unit difference, 90% Power, alpha 2.5% requires 276 in each arm, 3 arms 828, 20% attrition rate. Total 1035 Project timetable: Months 0-6 regulatory approvals, Months 6-18 pilot phase, Months 19-36 recruitment to full trial, Months 3-48 Follow up, Months 49-50 Completion of data analysis. Expertise in team Multi-disciplinary team with skills to deliver the study.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know