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Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03336229
Acronym
EFEx
Enrollment
72
Registered
2017-11-08
Start date
2018-04-30
Completion date
2020-10-31
Last updated
2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

cancer, colorectal, exercise, physical fitness

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.

Interventions

BEHAVIORALExercise intervention

Graduated walking programme, strengthening exercises and respiratory muscle training.

Sponsors

University of Southampton
CollaboratorOTHER
NHS Lanarkshire
CollaboratorOTHER_GOV
National Heatlh Service Ayrshire and Arran
CollaboratorOTHER_GOV
NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in cardiorespiratory fitnessPreoperative period: 4 weeksAnaerobic threshold as measured by CPET

Secondary

MeasureTime frameDescription
Length of stay in high dependency and intensive carePostoperative period: up to 8 weeksCritical Care bed days
Readmission to critical carePostoperative period: up to 8 weeks (within index admission)Critical Care bed days
Time to medical dischargePostoperative period: up to 8 weeks.Medically fit for discharge
Hospital length of stayPostoperative period: within 30 days.Days
Readmission rateWithin 30 days of discharge.
Post-operative morbidityPost-operative period: at 30 days post-surgery (week 8).Clavien-Dindo Scale
Health-related quality of lifeBaseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).SF-36
Psychological healthBaseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).Hospital Anxiety and Depression Score (HADS)
FrailtyBaseline (week 0) and repeat testing (week 4).Clinical Frailty Score (CSHA)
Redox blood samplesBaseline (week 0) and repeat CPET (week 4).Redox status in pre- and post-exercise blood samples
Survival3 years post-operatively.Overall and cancer-specific

Other

MeasureTime frameDescription
Feasibility of home-based exercisePreoperative period: 4 weeks.Recruitment, retention, adherence rates

Countries

United Kingdom

Contacts

Primary ContactKatrina A Knight
katrinaknight@nhs.net01413146965

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026