Pre-infusion Aerobic Cycling Exercise for CardioRespiratory Fitness in Cancer Patients
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Dublin, Trinity College
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged >18.
Disqualifiers
Advanced/metastatic disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Exercise ArmExperimental treatment 1 intervention
Group B: Education onlyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Enrolment (baseline)2
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.
Time frame
Weeks 1 to 123
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.
Time frame
Post-intervention (12 weeks)4
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.
Time frame
Post intervention (12 weeks)Secondary outcomes
1
Cardiorespiratory Fitness
CPETs will be performed on a cycle ergometer (h/p Cosmos model Cosmed E100) in the exercise physiology laboratory in the Beacon Orthopaedic Centre under the supervision of two exercise physiologists. The VO2peak test will be conducted on a cycle ergometer connected to the COSMED software. A standardised incremental ramp protocol will be used, commencing with a 2-minute phase of unloaded cycling. Followed by the ramped exercise phase with increases in workload (watts) to exhaustion in approximately 8-15 minutes for each individual. During CPET, Borg RPE scores will be recorded every 2 minutes and COSMED software captured the physiological measures from the breath-by-breath gas analyser with continuous monitoring of ventilation, carbon dioxide production, oxygen consumption and heart rate.
Time frame
Baseline & 12 weeks2
Body composition - Anthropometric measures
Weight (kilogrammes (kg)) and height (centimetres (cm)) will be recorded by standard methods using a calibrated scales and stadiometer (Seca 704 S Wireless Column Scale With Integrated Measuring Rod). Body mass index (BMI) will be calculated as weight (kg) divided by height (metres (m2)).
Time frame
Baseline & 12 weeks3
Body Composition - Air Displacement Plethysmography (ADP)
ADP will be used to determine body composition and will be performed using the 'Bod Pod'. Outputs from the Bod Pod provide multiple metrics of body composition. Measures recorded will include; fat mass, fat free mass, and skeletal muscle mass.
Time frame
Baseline & 12 weeks4
Health Related Quality of Life
Health-related quality of life will be determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 version 3.0) and its relevant subscales. The EORTC-QLQ-C30 manual advises that all of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptom burden or problems.
Time frame
Baseline & 12 weeksSponsors and contacts
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Source ClinicalTrials.gov