Colorectal CancerEFExNCT03336229
Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery
A study testing Exercise intervention in people with Colorectal Cancer, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Apr 2018to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary operable colorectal cancer;
- Awaiting surgery with curative intent;
- Deemed high risk by the responsible clinical team;
- Ability to mobilise independently
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Hairmyres Hospital
East Kilbride, G75 8RG
Grant Haldane, MBChB FRCA
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Katrina A Knight, MBChB
University Hospital Crosshouse
Kilmarnock, KA2 0BE
Laura McGarrity, MBChB FRCA
Royal Alexandra Hospital
Paisley, PA2 9PN
Katrina A Knight, MBChB, 01413146965, katrinaknight@nhs.net
Katrina A Knight, MBChB
About this study
Official title: The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Exercise intervention
- Keywords
- cancer, colorectal, exercise, physical fitness
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
Graduated walking programme, strengthening exercises and respiratory muscle training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Behavioral: Exercise intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness
Anaerobic threshold as measured by CPET
Measured: Preoperative period: 4 weeks
Secondary outcomes (12)
Length of stay in high dependency and intensive care
Critical Care bed days
Measured: Postoperative period: up to 8 weeks
Readmission to critical care
Critical Care bed days
Measured: Postoperative period: up to 8 weeks (within index admission)
Time to medical discharge
Medically fit for discharge
Measured: Postoperative period: up to 8 weeks.
Hospital length of stay
Days
Measured: Postoperative period: within 30 days.
Readmission rate
Measured: Within 30 days of discharge.
Post-operative morbidity
Clavien-Dindo Scale
Measured: Post-operative period: at 30 days post-surgery (week 8).
Health-related quality of life
SF-36
Measured: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Health-related quality of life
EORTC QLQ-C30
Measured: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Psychological health
Hospital Anxiety and Depression Score (HADS)
Measured: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Frailty
Clinical Frailty Score (CSHA)
Measured: Baseline (week 0) and repeat testing (week 4).
Redox blood samples
Redox status in pre- and post-exercise blood samples
Measured: Baseline (week 0) and repeat CPET (week 4).
Survival
Overall and cancer-specific
Measured: 3 years post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study startApr 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, NHS Lanarkshire, National Heatlh Service Ayrshire and Arran
- Responsible party
- Sponsor
- Investigators
- Katrina A Knight, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336229
- Sponsor's protocol ID
- GN16OG765
- Acronym
- EFEx
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery
- ClinicalTrials.gov ID
- NCT03336229
- Acronym / sponsor ID
- EFEx / GN16OG765
- Conditions
- Colorectal Cancer
- Keywords
- cancer, colorectal, exercise, physical fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Southampton, NHS Lanarkshire, National Heatlh Service Ayrshire and Arran
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Exercise intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary operable colorectal cancer;
- Awaiting surgery with curative intent;
- Deemed high risk by the responsible clinical team;
- Ability to mobilise independently
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionGraduated walking programme, strengthening exercises and respiratory muscle training. | Behavioural | Intervention |
Primary outcome
Change in cardiorespiratory fitness
Time frame: Preoperative period: 4 weeks
Anaerobic threshold as measured by CPET
12 secondary outcomes
Length of stay in high dependency and intensive care
Time frame: Postoperative period: up to 8 weeks
Readmission to critical care
Time frame: Postoperative period: up to 8 weeks (within index admission)
Time to medical discharge
Time frame: Postoperative period: up to 8 weeks.
Hospital length of stay
Time frame: Postoperative period: within 30 days.
Readmission rate
Time frame: Within 30 days of discharge.
Post-operative morbidity
Time frame: Post-operative period: at 30 days post-surgery (week 8).
Health-related quality of life
Time frame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Health-related quality of life
Time frame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Psychological health
Time frame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).
Frailty
Time frame: Baseline (week 0) and repeat testing (week 4).
Redox blood samples
Time frame: Baseline (week 0) and repeat CPET (week 4).
Survival
Time frame: 3 years post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrina A Knight principal investigator
NHS Greater Glasgow and Clyde
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Colorectal Cancer, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrina A Knight (01413146965, katrinaknight@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorespiratory fitness (time frame: Preoperative period: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.