Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery

Not Applicable

• Conditions: Colorectal Cancer

• 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.

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-11-03
• Last Update Submitted: 2017-11-03
• Study First Posted: 2017-11-08
• Last Update Posted: 2017-11-08
• Study Start: 2018-04
• Primary Completion: 2020-04
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Primary operable colorectal cancer;
• Awaiting surgery with curative intent;
• Deemed high risk by the responsible clinical team;
• Ability to mobilise independently

Exclusion Criteria

• 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

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)

Hairmyres Hospital; 🇬🇧 East Kilbride, United Kingdom

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom

University Hospital Crosshouse; 🇬🇧 Kilmarnock, United Kingdom

Royal Alexandra Hospital; 🇬🇧 Paisley, United Kingdom