Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

— EFEx  

Official title:

The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03336229
• Other study ID #: GN16OG765
• Status: Not yet recruiting
• Phase: N/A
• First received: September 21, 2017
• Last updated: November 3, 2017
• Start date: April 2018
• Est. completion date: October 2020

Study information

• Verified date: September 2017
• Source: NHS Greater Glasgow and Clyde
• Contact: Katrina A Knight
• Phone: 01413146965
• Email: katrinaknight[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: October 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Exercise intervention
Graduated walking programme, strengthening exercises and respiratory muscle training.

Locations

Country	Name	City	State
United Kingdom	Hairmyres Hospital	East Kilbride
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	University Hospital Crosshouse	Kilmarnock
United Kingdom	Royal Alexandra Hospital	Paisley

Sponsors (4)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	National Heatlh Service Ayrshire and Arran, NHS Lanarkshire, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of home-based exercise	Recruitment, retention, adherence rates	Preoperative period: 4 weeks.
Primary	Change in cardiorespiratory fitness	Anaerobic threshold as measured by CPET	Preoperative period: 4 weeks
Secondary	Length of stay in high dependency and intensive care	Critical Care bed days	Postoperative period: up to 8 weeks
Secondary	Readmission to critical care	Critical Care bed days	Postoperative period: up to 8 weeks (within index admission)
Secondary	Time to medical discharge	Medically fit for discharge	Postoperative period: up to 8 weeks.
Secondary	Hospital length of stay	Days	Postoperative period: within 30 days.
Secondary	Readmission rate		Within 30 days of discharge.
Secondary	Post-operative morbidity	Clavien-Dindo Scale	Post-operative period: at 30 days post-surgery (week 8).
Secondary	Health-related quality of life	SF-36	Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Secondary	Health-related quality of life	EORTC QLQ-C30	Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Secondary	Psychological health	Hospital Anxiety and Depression Score (HADS)	Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Secondary	Frailty	Clinical Frailty Score (CSHA)	Baseline (week 0) and repeat testing (week 4).
Secondary	Redox blood samples	Redox status in pre- and post-exercise blood samples	Baseline (week 0) and repeat CPET (week 4).
Secondary	Survival	Overall and cancer-specific	3 years post-operatively.