Supervised Exercise for Post-surgery Colorectal Cancer Patients
NCT ID: NCT05090215
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
21 participants
INTERVENTIONAL
2022-05-13
2024-01-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exercise Training in Colorectal Cancer Patients
NCT01325909
Preop CPET Testing and Exercise Training in Colorectal Patients
NCT01924897
Prospective Randomised Trial of Exercise and / or Antioxidants in COlorectal Cancer Patients Undergoing Surgery.
NCT02264496
CPET in Colorectal Surgery
NCT02298907
Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer Patients
NCT04762914
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recruitment Understandably for the potential recruits this will be a difficult and emotional time period given their significant diagnosis that will have been given very soon prior to the research team's first interaction with them. Participants will be recruited in the outpatient setting but after the diagnosis and treatment plan has been made and conveyed by their parent team. Patients will be given all the information and at least 48 hours to consider their involvement in the study. They will then be re-contacted them via telephone and if they agree, researchers who are trained in taking consent will complete the consent process with the patient. No patients will be included who lack capacity or are in any other way unable to give informed consent. The research group have previously recruited for several prehabilitation studies in this way with good patient feedback and no reports of psychological harm.
Exercise
These guidelines are suitable for older participants with necessary adaptations. However, it is assumed that a small number older of participants may struggle to achieve these targets as they were not achievable for them prior to diagnosis and surgery. The investigators have a long and safe track record of exercise in the elderly in studies performed by the group, and clinical researchers will closely supervise the CPET. Unfamiliarity with exercise in itself is not a reason for non-inclusion in the study, but a more graduated increase in effort may be required for individual participants. There are clear inclusion and exclusion criteria outlined to minimise the risk of adverse outcomes following exercise in the participants. Cardiopulmonary exercise testing (CPET) will be included in the functional assessments at four points during the study. There is a theoretical risk of exercise-induced pathology that may occur secondary to this. The guidelines will be followed for absolute contraindications as laid out by the POETTS consensus guidelines (2018) and ATS/ACCP statement on CPET (2003). These include but are not limited to:
* Acute myocardial infarction (3-5 days)
* Unstable angina
* Uncontrolled arrhythmias causing symptoms or hemodynamic compromise (200 mm Hg systolic, 120 mm Hg diastolic)
* Syncope
* Active endocarditis
* Acute myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Uncontrolled heart failure
* Acute pulmonary embolus or pulmonary infarction
* Thrombosis of lower extremities
* Suspected dissecting aneurysm
* Uncontrolled asthma
* Pulmonary edema
* Room air desaturation at rest
* Respiratory failure
* Acute non cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
* Mental impairment leading to inability to cooperate These patients will not be included in the study. Also, any abnormal results picked up at screening will warrant exclusion from the study, and the PI will communicate these to the participants' GP.
If any of the following occur both during exercise or CPET testing the programme will be terminated immediately and the participant withdrawn:
* Chest pain suggestive of ischaemia
* Ischemic ECG changes
* Complex ectopy
* Second or third degree heart block
* Fall in systolic pressure 20 mm Hg from the highest value during the test
* Hypertension (250 mm Hg systolic; 120 mm Hg diastolic)
* Severe desaturation: SpO2 ≤ 80% when accompanied by symptoms and signs of severe hypoxemia
* Sudden pallor
* Loss of coordination
* Mental confusion
* Dizziness or faintness
* Signs of respiratory failure CPET testing is the standard test for qualification of lack of cardiorespiratory fitness before operation and is used to stratify risk in higher risk patients as standard of care in the UK.
These guidelines will also be applied to those performing alternative forms of exercise such as brisk walking/running and resistance exercises. The resistance exercise component will via the use of resistance bands and therefore does not require equipment such as weight machines or free weights which can cause injury if applied incorrectly.
Those who volunteer for the study may be more active by virtue of a desire to be included. There is the potential for outcomes not being as generalizable to the whole population regardless of pre-existing physical activity, and also, impact of interventions may be lessened as both groups may be more fit than some groups of those who present for surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
All possible analysis will be done in a single blinded manner (e.g., analysis of ultrasound scans, CPET, blood samples etc).
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise intervention group
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.
Aerobic and resistance training 12 week exercise programme
See arm/group description
Venous blood sampling
full blood count, urea \& electrolytes, C-reactive protein, coagulation screen, liver function tests, erythrocyte sedimentation rate.
Muscle Ultrasound
Ultrasound of vastus lateralis to ascertain muscle structure (thickness, pennation angle and fascicle length)
Cardiopulmonary exercise testing (CPET)
The assessment of anaerobic threshold as a measure of changes in aerobic function between the two groups will be assessed using CPET
Quality of life questionnaire completion
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 group
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.
Venous blood sampling
full blood count, urea \& electrolytes, C-reactive protein, coagulation screen, liver function tests, erythrocyte sedimentation rate.
Muscle Ultrasound
Ultrasound of vastus lateralis to ascertain muscle structure (thickness, pennation angle and fascicle length)
Cardiopulmonary exercise testing (CPET)
The assessment of anaerobic threshold as a measure of changes in aerobic function between the two groups will be assessed using CPET
Quality of life questionnaire completion
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aerobic and resistance training 12 week exercise programme
See arm/group description
Venous blood sampling
full blood count, urea \& electrolytes, C-reactive protein, coagulation screen, liver function tests, erythrocyte sedimentation rate.
Muscle Ultrasound
Ultrasound of vastus lateralis to ascertain muscle structure (thickness, pennation angle and fascicle length)
Cardiopulmonary exercise testing (CPET)
The assessment of anaerobic threshold as a measure of changes in aerobic function between the two groups will be assessed using CPET
Quality of life questionnaire completion
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
University of Nottingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Nottingham, Royal Derby Hospital
Derby, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21058
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.