Clinical trial NCT03336229: Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery
Official title: The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: cancer
colorectal
exercise
physical fitness
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Southampton
name: NHS Lanarkshire
name: National Heatlh Service Ayrshire and Arran
First posted: 2017-11-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Preoperative period: 4 weeks
Secondary outcomes:
measure: Length of stay in high dependency and intensive care
timeFrame: Postoperative period: up to 8 weeks
measure: Readmission to critical care
timeFrame: Postoperative period: up to 8 weeks (within index admission)
measure: Time to medical discharge
timeFrame: Postoperative period: up to 8 weeks.
measure: Hospital length of stay
timeFrame: Postoperative period: within 30 days.
measure: Readmission rate
timeFrame: Within 30 days of discharge.
measure: Post-operative morbidity
timeFrame: Post-operative period: at 30 days post-surgery (week 8).
measure: Health-related quality of life
timeFrame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
measure: Health-related quality of life
timeFrame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
measure: Psychological health
timeFrame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
measure: Frailty
timeFrame: Baseline (week 0) and repeat testing (week 4).
measure: Redox blood samples
timeFrame: Baseline (week 0) and repeat CPET (week 4).
measure: Survival
timeFrame: 3 years post-operatively.
Other outcomes:
measure: Feasibility of home-based exercise
timeFrame: Preoperative period: 4 weeks.
Locations:
city: East Kilbride
country: United Kingdom
facility: Hairmyres Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Kilmarnock
country: United Kingdom
facility: University Hospital Crosshouse
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Katrina A Knight
role: PRINCIPAL_INVESTIGATOR
References: