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Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery

NCT ID: NCT03336229

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Keywords

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cancer colorectal exercise physical fitness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Group Type ACTIVE_COMPARATOR

Exercise intervention

Intervention Type BEHAVIORAL

Graduated walking programme, strengthening exercises and respiratory muscle training.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise intervention

Graduated walking programme, strengthening exercises and respiratory muscle training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southampton

OTHER

Sponsor Role collaborator

NHS Lanarkshire

OTHER_GOV

Sponsor Role collaborator

National Heatlh Service Ayrshire and Arran

OTHER_GOV

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katrina A Knight

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

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Hairmyres Hospital

East Kilbride, , United Kingdom

Site Status

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status

University Hospital Crosshouse

Kilmarnock, , United Kingdom

Site Status

Royal Alexandra Hospital

Paisley, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Katrina A Knight

Role: CONTACT

Phone: 01413146965

Email: [email protected]

Facility Contacts

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Katrina A Knight, MBChB

Role: primary

Other Identifiers

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GN16OG765

Identifier Type: -

Identifier Source: org_study_id