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Status unknownNCT03336229EFExUpdated Nov 8, 2017

Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery

An interventional study of Exercise intervention in Colorectal Cancer, sponsored by NHS Greater Glasgow and Clyde. Status unknown at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-08.

Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 387 studies in Colorectal Neoplasms with a site in United Kingdom — 73 open to participants now, 101 under way, 18 of them phase 3. Colorectal Neoplasms · United Kingdom.

Planned enrollment
207th of 299
72 · median 150
Started
2018
with 10 others
No phase
64 of 387
12 open now
Registered
205th of 387
by date

Among the 387 studies in Colorectal Neoplasms with a site in United Kingdom, this one is the 207th largest by planned enrollment of the 299 interventional ones that give a count, is one of 11 that started in 2018, is one of 64 with no phase, and was the 205th registered.

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

73 of the 387 studies in Colorectal Neoplasms with a site in United Kingdom are open now. Recruiting first, the newest first:

68 more — sign in →

All 73 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Colorectal Cancer

Keywords

  • cancer
  • colorectal
  • exercise
  • physical fitness
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Active comparator
    Intervention

    Behavioral: Exercise intervention

  • No intervention
    Control

Interventions

  • BehavioralExercise intervention

    Graduated walking programme, strengthening exercises and respiratory muscle training.

06

What researchers measure

Primary outcomes

  1. Change in cardiorespiratory fitness

    Anaerobic threshold as measured by CPET

    Time frame: Preoperative period: 4 weeks

Secondary outcomes

  1. Length of stay in high dependency and intensive care

    Critical Care bed days

    Time frame: Postoperative period: up to 8 weeks

  2. Readmission to critical care

    Critical Care bed days

    Time frame: Postoperative period: up to 8 weeks (within index admission)

  3. Time to medical discharge

    Medically fit for discharge

    Time frame: Postoperative period: up to 8 weeks.

  4. Hospital length of stay

    Days

    Time frame: Postoperative period: within 30 days.

  5. Readmission rate

    Time frame: Within 30 days of discharge.

  6. Post-operative morbidity

    Clavien-Dindo Scale

    Time frame: Post-operative period: at 30 days post-surgery (week 8).

  7. Health-related quality of life

    SF-36

    Time frame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).

  8. Health-related quality of life

    EORTC QLQ-C30

    Time frame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).

  9. Psychological health

    Hospital Anxiety and Depression Score (HADS)

    Time frame: Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).

  10. Frailty

    Clinical Frailty Score (CSHA)

    Time frame: Baseline (week 0) and repeat testing (week 4).

  11. Redox blood samples

    Redox status in pre- and post-exercise blood samples

    Time frame: Baseline (week 0) and repeat CPET (week 4).

  12. Survival

    Overall and cancer-specific

    Time frame: 3 years post-operatively.

Other outcomes

  1. Feasibility of home-based exercise

    Recruitment, retention, adherence rates

    Time frame: Preoperative period: 4 weeks.

07

Study locations

4 sites
  • Hairmyres Hospital
    East Kilbride, G75 8RG, United Kingdom
    • Grant Haldane, MBChB FRCA · Principal investigator
  • Queen Elizabeth University Hospital
    Glasgow, G51 4TF, United Kingdom
    • Katrina A Knight, MBChB · Principal investigator
  • University Hospital Crosshouse
    Kilmarnock, KA2 0BE, United Kingdom
    • Laura McGarrity, MBChB FRCA · Principal investigator
  • Royal Alexandra Hospital
    Paisley, PA2 9PN, United Kingdom
    • Katrina A Knight, MBChB · Contactkatrinaknight@nhs.net · 01413146965
    • Katrina A Knight, MBChB · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2018; primary completion for Apr 2020, 24 months later.

Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 24 months is below that.

Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2017
First posted
Nov 8, 2017
StartEst.
Apr 2018
Primary completionEst.
Apr 2020
CompletionEst.
Oct 2020
Last update
Nov 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03336229
Collaborators
University of Southampton, NHS Lanarkshire, National Heatlh Service Ayrshire and Arran
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Apr 2018 (estimated)
Primary completion
Apr 2020 (estimated)
Completion
Oct 2020 (estimated)
Last update
Nov 8, 2017

Study contacts

Katrina A Knight
Contact
katrinaknight@nhs.net
01413146965
Katrina A Knight
principal investigator · NHS Greater Glasgow and Clyde

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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