Clinical trial · Interventional
Supervised Exercise for Post-surgery Colorectal Cancer Patients
A Randomised Controlled Trial to Assess the Efficacy of a Postoperative Supervised Exercise Programme in Patients Who Have Undergone Elective Curative Surgery for Colorectal Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic and resistance training 12 week exercise programme | Behavioral | — | UNRESOLVED |
| Cardiopulmonary exercise testing (CPET) | Diagnostic Test | — | UNRESOLVED |
| Muscle Ultrasound | Diagnostic Test | — | UNRESOLVED |
| Quality of life questionnaire completion | Behavioral | — | UNRESOLVED |
| Venous blood sampling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Exercise intervention group
- description
- 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.
- interventionNames
- Behavioral: Aerobic and resistance training 12 week exercise programme
- Diagnostic Test: Venous blood sampling
- Diagnostic Test: Muscle Ultrasound
- Diagnostic Test: Cardiopulmonary exercise testing (CPET)
- Behavioral: Quality of life questionnaire completion
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years and over MDT outcome of proven or high clinical suspicion of colorectal cancer Due to undergo either laparoscopic, robotic or open resection with curative intent Ability to exercise on a static bike (in order to complete the CPET, not required for the exercise programme) Ability to give informed consent Must be able to their organize own transport to RDH for the duration of the study in order to complete the supervised exercise sessions Availability for the period of study inclusion Exclusion Criteria: * 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
References
Publications (2)
- BACKGROUNDBlackwell 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 32157250
- BACKGROUNDLevett 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 29452805