NCT05090215Completed
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 · Last updated 16 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 28 Sept 2021
- Start date
- 13 May 2022
- Primary completion date
- 27 Jan 2024
- Lead sponsor
- University of Nottingham
- Diseases
- Colorectal cancer
- NCT number
- NCT05090215
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 13 May 2022 to the primary completion date, 27 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who lack capacity to consent Participants with a new diagnosis undergoing emergency surgery
- Participants with a past medical history including the following:
- Previous stroke/TIA
Other illness
- 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)
- Severe respiratory disease including known pulmonary hypertension (\>25mmHg)
Other
- Cerebral or abdominal aortic aneurysm
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Nottingham, Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.