NCT05090215

Brief Summary

Participants will undergo preoperative baseline screening and will be randomised to either normal postoperative care or a 12-week supervised exercise programme comprising of both an aerobic and resistance component They will be assessed prior to surgery which will include cardiopulmonary exercise testing (CPET). This is a well-established method of assessing aerobic exercise response and is widely used in the perioperative period for assessment of cancer patients with co-morbidity. The assessment days will also include:

  • muscle ultrasound (vastus lateralis) to ascertain muscle structure (thickness, pennation angle and fascicle length),
  • blood tests,
  • functional composite scores,
  • quality of life questionnaires, The assessment days will be carried out at four time points during the study; prior to surgery, before commencement of the exercise program, halfway through the intervention (6 weeks post commencement of exercise) and at the end of the study. In the week before the assessment days patients will wear a physical activity monitor to characterise their daily movements. The control group will also be assessed at the same time points and wear the activity monitors but will not take part in the exercise program. All participants will have a physical activity monitor placed onto the right thigh in the midline at postoperative day 1 until discharge or day 7, whichever is sooner. This is a non-invasive measure of activity and can discriminate between whether a patient is lying, sitting, standing or walking. Once participants self-report feeling able to start exercising again post-discharge, they will commence the 12 week programme. The intervention will consist of 2 resistance training (RET) sessions per week and 75 minutes of vigorous or 150 minutes of moderate aerobic exercise per week (can be split according to patient preference). They will receive a diary to log their sessions and will be monitored via twice weekly virtual follow-up (either telephone or video calling) and for the first 6 weeks weekly visits to ensure that they are adherent to the exercise protocol and provide any support/advice. Satisfactory compliance with the programme will be considered to be the completion of at least 27 sessions over the 12 week period, with a minimum of 13 out of 18 and 14 out of 18 sessions completed in the first and last 6 weeks, respectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

May 13, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2024

Completed
Last Updated

July 16, 2025

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

September 28, 2021

Last Update Submit

July 10, 2025

Conditions

Colorectal CancerColorectal Neoplasms

Keywords

exerciserehabilitationpostoperativecolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Anaerobic threshold change

    To achieve a significant increase in anaerobic threshold (AT) on CPET (above 2.26ml/kg/min) in a cohort of colorectal cancer patients who have undergone surgery with curative intent following a 12-week combined aerobic and resistance exercise program compared to control.

    12 weeks from the commencement of the exercise programme

Secondary Outcomes (4)

  • To assess whether all participants are able to complete the 12 week postoperative exercise programme (measured via study adherence and compliance)

    12 weeks from the commencement of the exercise programme

  • Quality of life improvements as reported by participants via validated questionnaires after application of a 12 week postoperative exercise programme

    12 weeks from the commencement of the exercise programme

  • Measure any changes see to vastus lateralis muscle composition via ultrasound after application of a 12 week postoperative exercise programme

    12 weeks from the commencement of the exercise programme

  • Change to the values inflammatory markers using venous blood samples after the application of a 12 week postoperative exercise programme

    12 weeks from the commencement of the exercise programme

Study Arms (2)

Exercise intervention group

ACTIVE COMPARATOR

2 resistance training session per week using a home-based resistance training pack and 75 minutes of vigorous or 150 minutes of moderate aerobic exercise per week (as per UK government guidelines) for 12 weeks. They will have 4 assessment points, pre-op, prior to the start of the exercise programme postoperatively, at 6 weeks post commencement of exercise and at 12 weeks to conclude the study. The assessment will include bloods, cardiopulmonary exercise testing, muscle ultrasound to ascertain muscle structure, functional composite scores and quality of life questionnaires.

Behavioral: Aerobic and resistance training 12 week exercise programmeDiagnostic Test: Venous blood samplingDiagnostic Test: Muscle UltrasoundDiagnostic Test: Cardiopulmonary exercise testing (CPET)Behavioral: Quality of life questionnaire completion

Control group

PLACEBO COMPARATOR

This group will receive standard postoperative care. They will also have 4 assessment points, pre-op, prior to the start of their standard postoperative care, 6 and finally 12 weeks later to conclude the study. The assessment will include bloods, cardiopulmonary exercise testing, muscle ultrasound to ascertain muscle structure, functional composite scores and quality of life questionnaires.

Diagnostic Test: Venous blood samplingDiagnostic Test: Muscle UltrasoundDiagnostic Test: Cardiopulmonary exercise testing (CPET)Behavioral: Quality of life questionnaire completion

Interventions

Aerobic and resistance training 12 week exercise programmeBEHAVIORAL

See arm/group description

Exercise intervention group
Venous blood samplingDIAGNOSTIC_TEST

full blood count, urea \& electrolytes, C-reactive protein, coagulation screen, liver function tests, erythrocyte sedimentation rate.

Control groupExercise intervention group
Muscle UltrasoundDIAGNOSTIC_TEST

Ultrasound of vastus lateralis to ascertain muscle structure (thickness, pennation angle and fascicle length)

Control groupExercise intervention group
Cardiopulmonary exercise testing (CPET)DIAGNOSTIC_TEST

The assessment of anaerobic threshold as a measure of changes in aerobic function between the two groups will be assessed using CPET

Control groupExercise intervention group
Quality of life questionnaire completionBEHAVIORAL

The use of validated questionnaires to assess quality of life parameters; Duke Activity Status Index (DASI), EORTC-QLQ C30 (quality of life for cancer patients) and the International Physical Activity Questionnaire (IPAQ).

Control groupExercise intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Participants who lack capacity to consent Participants with a new diagnosis undergoing emergency surgery
  • Participants with a past medical history including the following:
  • Recent myocardial infarction (MI) in the last 6 months or unstable angina Heart failure (New York Heart Association Class III/IV)
  • Uncontrolled hypertension (BP\>160/100)
  • Previous stroke/TIA
  • Cerebral or abdominal aortic aneurysm
  • Severe respiratory disease including known pulmonary hypertension (\>25mmHg)
  • Exercise induced asthma or brittle asthma Abnormal blood and/or ECG results Patients who are unable to undergo CPET according to the Perioperative Exercise Testing and Training Society (POETTS) published consensus guidelines on performing CPET

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham, Royal Derby Hospital

Derby, DE22 3DT, United Kingdom

Location

Related Publications (2)

  • Blackwell JEM, Doleman B, Boereboom CL, Morton A, Williams S, Atherton P, Smith K, Williams JP, Phillips BE, Lund JN. High-intensity interval training produces a significant improvement in fitness in less than 31 days before surgery for urological cancer: a randomised control trial. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):696-704. doi: 10.1038/s41391-020-0219-1. Epub 2020 Mar 10.

    PMID: 32157250BACKGROUND

  • Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.

    PMID: 29452805BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsMotor Activity

Interventions

Resistance TrainingBlood Specimen CollectionExercise Test

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometry

Study Officials

  • Jon Lund, MD, FRCS

    jon.lund@nottingham.ac.uk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Randomization will occur using www.sealedenvelope.com. This will be performed by a member of the research team on the patient's first visit. Patients will not be blinded due to the active nature of the intervention. Any independent review performed of data will be done by a researcher who has been blinded to group allocation. All possible analysis will be done in a single blinded manner (e.g., analysis of ultrasound scans, CPET, blood samples etc).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single centre randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 22, 2021

Study Start

May 13, 2022

Primary Completion

January 27, 2024

Study Completion

January 27, 2024

Last Updated

July 16, 2025

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)