Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery
- Conditions
- Colorectal Cancer
- Interventions
- Behavioral: Exercise intervention
- Registration Number
- NCT03336229
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- Brief Summary
This study examines whether a home-based telephone-guided preoperative exercise programme is feasible and effective in improving cardiorespiratory fitness in patients with colorectal cancer who are high risk due to their existing co-morbidity.
- Detailed Description
Preoperative exercise, also know as prehabilitation, has been shown to improve physical fitness and potentially reduce postoperative complications in patients undergoing surgery. Patients are often labelled high risk for surgery due to their existing ill-health e.g. heart and lung disease. High risk patients comprise approximately 12% of all elective cancer cases, but account for 80% of all post-operative mortality. Complications significantly affect the quality of life of each CRC patient, both in the short and long-term, and can also impact on survival. It is critical that patients who are deemed at high risk of complications are optimised in the preoperative period. Exercise in the period before surgery is therefore one potential method of improving high risk patients' physical fitness levels while potentially reducing their risk of postoperative complications and subsequent mortality.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- Primary operable colorectal cancer;
- Awaiting surgery with curative intent;
- Deemed high risk by the responsible clinical team;
- Ability to mobilise independently
- Patients with primary or recurrent inoperable colorectal cancer.
- Patients undergoing preoperative chemo- and/or radiotherapy.
- Patients who decline or are deemed unfit for operative management.
- Patients who lack capacity to consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Exercise intervention -
- Primary Outcome Measures
Name Time Method Change in cardiorespiratory fitness Preoperative period: 4 weeks Anaerobic threshold as measured by CPET
- Secondary Outcome Measures
Name Time Method Hospital length of stay Postoperative period: within 30 days. Days
Survival 3 years post-operatively. Overall and cancer-specific
Readmission rate Within 30 days of discharge. Health-related quality of life Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8). EORTC QLQ-C30
Post-operative morbidity Post-operative period: at 30 days post-surgery (week 8). Clavien-Dindo Scale
Psychological health Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8). Hospital Anxiety and Depression Score (HADS)
Frailty Baseline (week 0) and repeat testing (week 4). Clinical Frailty Score (CSHA)
Length of stay in high dependency and intensive care Postoperative period: up to 8 weeks Critical Care bed days
Readmission to critical care Postoperative period: up to 8 weeks (within index admission) Critical Care bed days
Time to medical discharge Postoperative period: up to 8 weeks. Medically fit for discharge
Redox blood samples Baseline (week 0) and repeat CPET (week 4). Redox status in pre- and post-exercise blood samples
Trial Locations
- Locations (4)
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Hairmyres Hospital
🇬🇧East Kilbride, United Kingdom
University Hospital Crosshouse
🇬🇧Kilmarnock, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, United Kingdom