Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery (EFEx)

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Exercise intervention

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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrina A Knight; Phone Number: 01413146965; Email: katrinaknight@nhs.net

Study Locations

• United Kingdom
  • East Kilbride, United Kingdom, G75 8RG
    • Hairmyres Hospital
    • Principal Investigator: Grant Haldane, MBChB FRCA
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital
    • Principal Investigator: Katrina A Knight, MBChB
  • Kilmarnock, United Kingdom, KA2 0BE
    • University Hospital Crosshouse
    • Principal Investigator: Laura McGarrity, MBChB FRCA
  • Paisley, United Kingdom, PA2 9PN
    • Royal Alexandra Hospital
    • Principal Investigator: Katrina A Knight, MBChB
    • Contact: Katrina A Knight, MBChB; Phone Number: 01413146965; Email: katrinaknight@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: Intervention	Behavioral: Exercise intervention; Graduated walking programme, strengthening exercises and respiratory muscle training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiorespiratory fitness	Anaerobic threshold as measured by CPET	Preoperative period: 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in high dependency and intensive care	Critical Care bed days	Postoperative period: up to 8 weeks
Readmission to critical care	Critical Care bed days	Postoperative period: up to 8 weeks (within index admission)
Time to medical discharge	Medically fit for discharge	Postoperative period: up to 8 weeks.
Hospital length of stay	Days	Postoperative period: within 30 days.
Readmission rate		Within 30 days of discharge.
Post-operative morbidity	Clavien-Dindo Scale	Post-operative period: at 30 days post-surgery (week 8).
Health-related quality of life	SF-36	Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Health-related quality of life	EORTC QLQ-C30	Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Psychological health	Hospital Anxiety and Depression Score (HADS)	Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Frailty	Clinical Frailty Score (CSHA)	Baseline (week 0) and repeat testing (week 4).
Redox blood samples	Redox status in pre- and post-exercise blood samples	Baseline (week 0) and repeat CPET (week 4).
Survival	Overall and cancer-specific	3 years post-operatively.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of home-based exercise	Recruitment, retention, adherence rates	Preoperative period: 4 weeks.

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Southampton; NHS Lanarkshire; National Heatlh Service Ayrshire and Arran
• Investigators: Principal Investigator: Katrina A Knight, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: exercise; cancer; colorectal; physical fitness
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: GN16OG765

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No