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

NCT07182773 | Recruiting

• 2 other identifiers: TRI CRF 24-02AHP24MCG
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

exercise; cardiorespiratory fitness; chemotherapy; exercise oncology

Outcome Measures

Primary Outcomes (4)

• Feasibility - Recruitment Rates

  Recruitment rates will be calculated as the percentage of eligible participants who agreed to take part in the study. Recruitment rates will be calculated for each recruitment timepoint to determine which timepoint yields optimal recruitment. Reasons for declining recruitment will also be recorded.

  Enrolment (baseline)

• Feasibility - Adherence Rates

  Exercise adherence will be used to measure the degree to which the participants performed the exercise at the desired intensity and time. After each exercise session, participants will be asked to rate their perceived exertion that they actually achieved during the exercise session. This RPE will be compared to the moderate intensity (BORG 4-6) intensity prescribed to determine adherence to intensity. Heart rate data recorded during the exercise session will also be compared with target heart rate prescribed to assess adherence to intensity. The Adherence to exercise time will be calculated by recording the total number of minutes spent cycling in each session compared to the 30 minute cycling target.

  Weeks 1 to 12

• Feasibility - Retention Rates

  Retention rates will be calculated as the number of participants completing the post intervention assessment. Reasons for dropout will also be recorded.

  Post-intervention (12 weeks)

• Feasibility - Satisfaction

  Qualitative data will be used to analyse the overall delivery of the exercise programme and suitability of intervention characteristics. Qualitative data will be collected using satisfaction questionnaires.

  Post intervention (12 weeks)

Secondary Outcomes (6)

• Cardiorespiratory Fitness

  Baseline & 12 weeks

• Body composition - Anthropometric measures

  Baseline & 12 weeks

• Body Composition - Air Displacement Plethysmography (ADP)

  Baseline & 12 weeks

• Health Related Quality of Life

  Baseline & 12 weeks

• Fatigue

  Baseline & 12 weeks

Study Arms (2)

Exercise Arm

EXPERIMENTAL

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.

Behavioral: Exercise

Education only

NO INTERVENTION

The control group will receive education on the physical activity recommendations during cancer treatment as per standard care

Interventions

Exercise BEHAVIORAL

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.

Exercise Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

Beacon Hospital Dublin

Dublin, Ireland

RECRUITING

Related Publications (1)

• Kearney N, Connolly D, Begic S, Mockler D, Guinan E. Feasibility metrics of exercise interventions during chemotherapy: A systematic review. Crit Rev Oncol Hematol. 2024 Mar;195:104272. doi: 10.1016/j.critrevonc.2024.104272. Epub 2024 Jan 23.

  PMID: 38272152 RESULT

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Aoife McGovern

CONTACT

+3531 293 6692; physiotherapy@beaconhospital.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of this study, blinding of the participants and the exercise professional delivering the intervention is not possible. The exercise physiologist completing baseline (T0) and post-intervention (T1) CPET assessments will be blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 19, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)