RecruitingNot ApplicableNCT07182773

Pre-infusion Aerobic Cycling Exercise for CardioRespiratory Fitness in Cancer Patients

Sponsor

University of Dublin, Trinity College

Enrollment

80 participants

Start Date

Sep 24, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer

Summary

Background to this Research Patients who undergo cancer treatment involving chemotherapy or immunotherapy, can experience considerable reductions in their fitness levels. This is a concern, as exercise is a really important part of cancer care. Therefore delivering exercise programmes that support patients during their chemotherapy or immunotherapy treatment will be essential to helping people to maintain their fitness levels. Research is needed to examine the best way to introduce exercise into the patient pathway in a way that is convenient and patient-centred. The Specific Questions Being Asked This research project aims to examine the effect of an exercise programme which involves exercising on the cancer treatment day ward with a physiotherapist while waiting for treatment infusion as a safe and effective way of supporting patients to keep fit and active during chemotherapy treatment. The trial will also investigate if it the prescribed moderate intensity exercise for 30 minutes is manageable for patients. Trial Plan This project will be delivered as a randomised controlled trial. All participants enrolled on the trial will receive information and advice about physical activity during chemotherapy treatment from a physiotherapist with expertise in cancer care. The intervention arm will also complete an exercise session with the physiotherapist on the day of their infusion treatment over a period of 12 weeks. The feasibility of this protocol has already been tested in 17 participants with very positive results. The information gained from this initial study will be used to deliver this trial, which will recruit 80 participants. It is hoped that the information gained from this research will provide a practical way of providing supervised exercise training for patients during chemotherapy or immunotherapy that is safe, expert-led and patient centred.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Aged >18.
Histological confirmed diagnosis of stage I to IIIc breast, ovarian, or colorectal cancer.
Scheduled to receive chemotherapy ± immunotherapy with curative intent over at least a 12-week period.
Medical clearance from oncologist to partake in regular exercise in accordance with ACSM preparticipation screening algorithm.
Able to use exercise bike independently.
Ability to provide written informed consent.

Exclusion Criteria10

Advanced/metastatic disease.
Scheduled to receive concurrent chemoradiotherapy.
New pain or other pain that would preclude ability to use bike.
Inability to read and understand English.
Deemed unfit to proceed from results of CPET.
Unstable angina, arrhythmia, hypertension or decompensated heart failure.
Dementia or psychiatric illness which would preclude safe independent exercise.
Acute untreated embolus/infarct.
Dissecting aneurysm.
Acute myocarditis or pericarditis.

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Interventions

BEHAVIORALExercise

The exercise programme will be prescribed at a moderate intensity (Target Heart rate: 60%-65% Heart Rate Reserve + resting heart rate) for 30 minutes immediately prior to infusion therapy, on their treatment days over 12- weeks. Exercise will be completed on a stationary cycle ergometer. Target heart rate will be adjusted to 50-55% Heart Rate Reserve + resting heart rate if patient is complaining of fatigue/nausea, is on beta-blockers or if haemoglobin \<9g/dL. Heart rate monitoring by chest strap using the polar heart rate monitor will allow participants to self-regulate their exercise intensity. Participants should discontinue exercise and await medical review if they develop chest pain, dizziness or pre-syncope, cyanosis or pallor appearance, new musculoskeletal pain.