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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise intervention
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer focused on measuring cancer, colorectal, exercise, physical fitness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hairmyres Hospital
  • Queen Elizabeth University Hospital
  • University Hospital Crosshouse
  • Royal Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in cardiorespiratory fitness
Anaerobic threshold as measured by CPET

Secondary Outcome Measures

Length of stay in high dependency and intensive care
Critical Care bed days
Readmission to critical care
Critical Care bed days
Time to medical discharge
Medically fit for discharge
Hospital length of stay
Days
Readmission rate
Post-operative morbidity
Clavien-Dindo Scale
Health-related quality of life
SF-36
Health-related quality of life
EORTC QLQ-C30
Psychological health
Hospital Anxiety and Depression Score (HADS)
Frailty
Clinical Frailty Score (CSHA)
Redox blood samples
Redox status in pre- and post-exercise blood samples
Survival
Overall and cancer-specific

Full Information

First Posted
September 21, 2017
Last Updated
November 3, 2017
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Southampton, NHS Lanarkshire, National Heatlh Service Ayrshire and Arran
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1. Study Identification

Unique Protocol Identification Number
NCT03336229
Brief Title
Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery
Acronym
EFEx
Official Title
The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Southampton, NHS Lanarkshire, National Heatlh Service Ayrshire and Arran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
cancer, colorectal, exercise, physical fitness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention
Intervention Description
Graduated walking programme, strengthening exercises and respiratory muscle training.
Primary Outcome Measure Information:
Title
Change in cardiorespiratory fitness
Description
Anaerobic threshold as measured by CPET
Time Frame
Preoperative period: 4 weeks
Secondary Outcome Measure Information:
Title
Length of stay in high dependency and intensive care
Description
Critical Care bed days
Time Frame
Postoperative period: up to 8 weeks
Title
Readmission to critical care
Description
Critical Care bed days
Time Frame
Postoperative period: up to 8 weeks (within index admission)
Title
Time to medical discharge
Description
Medically fit for discharge
Time Frame
Postoperative period: up to 8 weeks.
Title
Hospital length of stay
Description
Days
Time Frame
Postoperative period: within 30 days.
Title
Readmission rate
Time Frame
Within 30 days of discharge.
Title
Post-operative morbidity
Description
Clavien-Dindo Scale
Time Frame
Post-operative period: at 30 days post-surgery (week 8).
Title
Health-related quality of life
Description
SF-36
Time Frame
Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Title
Health-related quality of life
Description
EORTC QLQ-C30
Time Frame
Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Title
Psychological health
Description
Hospital Anxiety and Depression Score (HADS)
Time Frame
Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Title
Frailty
Description
Clinical Frailty Score (CSHA)
Time Frame
Baseline (week 0) and repeat testing (week 4).
Title
Redox blood samples
Description
Redox status in pre- and post-exercise blood samples
Time Frame
Baseline (week 0) and repeat CPET (week 4).
Title
Survival
Description
Overall and cancer-specific
Time Frame
3 years post-operatively.
Other Pre-specified Outcome Measures:
Title
Feasibility of home-based exercise
Description
Recruitment, retention, adherence rates
Time Frame
Preoperative period: 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina A Knight
Phone
01413146965
Email
katrinaknight@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrina A Knight
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hairmyres Hospital
City
East Kilbride
ZIP/Postal Code
G75 8RG
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grant Haldane, MBChB FRCA
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina A Knight, MBChB
Facility Name
University Hospital Crosshouse
City
Kilmarnock
ZIP/Postal Code
KA2 0BE
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura McGarrity, MBChB FRCA
Facility Name
Royal Alexandra Hospital
City
Paisley
ZIP/Postal Code
PA2 9PN
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina A Knight, MBChB
Phone
01413146965
Email
katrinaknight@nhs.net
First Name & Middle Initial & Last Name & Degree
Katrina A Knight, MBChB

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery

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