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
1 other identifier
interventional
72
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Apr 2018
Typical duration for not_applicable colorectal-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2017
CompletedFirst Posted
Study publicly available on registry
November 8, 2017
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 8, 2017
September 1, 2017
2 years
September 21, 2017
November 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in cardiorespiratory fitness
Anaerobic threshold as measured by CPET
Preoperative period: 4 weeks
Secondary Outcomes (12)
Length of stay in high dependency and intensive care
Postoperative period: up to 8 weeks
Readmission to critical care
Postoperative period: up to 8 weeks (within index admission)
Time to medical discharge
Postoperative period: up to 8 weeks.
Hospital length of stay
Postoperative period: within 30 days.
Readmission rate
Within 30 days of discharge.
- +7 more secondary outcomes
Other Outcomes (1)
Feasibility of home-based exercise
Preoperative period: 4 weeks.
Study Arms (2)
Intervention
ACTIVE COMPARATORControl
NO INTERVENTIONInterventions
Graduated walking programme, strengthening exercises and respiratory muscle training.
Eligibility Criteria
You may qualify if:
- Primary operable colorectal cancer;
- Awaiting surgery with curative intent;
- Deemed high risk by the responsible clinical team;
- Ability to mobilise independently
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Southamptoncollaborator
- NHS Lanarkshirecollaborator
- National Heatlh Service Ayrshire and Arrancollaborator
Study Sites (4)
Hairmyres Hospital
East Kilbride, G75 8RG, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
University Hospital Crosshouse
Kilmarnock, KA2 0BE, United Kingdom
Royal Alexandra Hospital
Paisley, PA2 9PN, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katrina A Knight
NHS Greater Glasgow and Clyde
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2017
First Posted
November 8, 2017
Study Start
April 1, 2018
Primary Completion
April 1, 2020
Study Completion
October 1, 2020
Last Updated
November 8, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share