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Clinical Trials/NCT03336229
NCT03336229
Unknown
Not Applicable

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

NHS Greater Glasgow and Clyde4 sites in 1 country72 target enrollmentApril 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
NHS Greater Glasgow and Clyde
Enrollment
72
Locations
4
Primary Endpoint
Change in cardiorespiratory fitness
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2018
End Date
October 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in cardiorespiratory fitness

Time Frame: Preoperative period: 4 weeks

Anaerobic threshold as measured by CPET

Secondary Outcomes

  • Hospital length of stay(Postoperative period: within 30 days.)
  • Survival(3 years post-operatively.)
  • 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).)
  • Post-operative morbidity(Post-operative period: at 30 days post-surgery (week 8).)
  • Psychological health(Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).)
  • Frailty(Baseline (week 0) and repeat testing (week 4).)
  • 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.)
  • Redox blood samples(Baseline (week 0) and repeat CPET (week 4).)

Study Sites (4)

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