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FiGHTING F!T: An exercise program for adolescents and young adults during cancer treatment in Western Australia

FiGHTING F!T: A randomised controlled trial determining the effect of a structured supervised exercise intervention on physical fitness during treatment for cancer in adolescents and young adults in Western Australia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000663954
Acronym
N/A
Enrollment
43
Registered
2020-06-10
Start date
2018-12-03
Completion date
2021-01-13
Last updated
2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to assess if a structured exercise program will have an effect on physical fitness, strength and quality of life. We also aim to assess if exercise has any impact on treatment related side effects or chemotherapy dosage modifications. Who is it for? You may be eligible for this study if you are aged between 15-25 years old and have either commenced treatment for cancer in the past two weeks or are due to commence in the next two weeks. Study details Participants enrolled in this study will be randomly divided into two groups: - Group 1 will receive an exercise program shortly after enrolling in this study, which will involve both aerobic exercise (walking, cycling, etc.) and a strength component. Participants in this group will need to attend two face-to-face exercise sessions per week and are also expected to complete some exercise at home, for 10 weeks. - Group 2 will need to record the exercise they complete in their day-to-day activities for 10 weeks. After this, they will then also receive an exercise program similar to that completed by Group 1. As part of this study, all participants will need to complete questionnaires and functional assessments at baseline, week 10, and week 20. Participants will also be required to undergo weekly blood tests to ensure they are within safety parameters to complete the exercise program. These results will also be used to record any treatment toxicities. It is hoped that this research will help in determining if exercise is effective in decreasing decline in physical fitness, while also improving psychosocial outcomes during cancer treatment.

Interventions

Following patients providing informed consent and consent being sought by the participants treating clinician participants will undergo a baseline assessment. This assessment is conducted by an Accredited Exercise Physiologist (AEP) and is repeated at 10 weeks and 20weeks post recruitment. The following parameters will be collected at baseline, ten weeks and twenty weeks: • Demographic information: diagnosis, treatment, medical history. • Cardiopulmonary Exercise Testing (CPEX): to measure sub

Following patients providing informed consent and consent being sought by the participants treating clinician participants will undergo a baseline assessment. This assessment is conducted by an Accredited Exercise Physiologist (AEP) and is repeated at 10 weeks and 20weeks post recruitment. The following parameters will be collected at baseline, ten weeks and twenty weeks: • Demographic information: diagnosis, treatment, medical history. • Cardiopulmonary Exercise Testing (CPEX): to measure submaximal oxygen consumption (Vo2peak) • Anthropometrics: Body mass, height, BMI, waist/hip circumference. • Strength: 1 repetition maximum (1RM) for leg press, row and chest press strength grip strength • Physical function: 30sec push up, sit ups, sit to stand. • Body composition: using dual energy x-ray absorptiometry (DEXA) to measure fat mass, muscle mass and bone mineral density. The following feasibility data will be collected and analysed throughout the study period: • Adverse events • Information relating to withdrawal from the study • Adherence to the exercise intervention • Compliance to the study protocol. Stratification and randomisation Following baseline assessment participants will be randomised by stratified permuted block randomisation. Patients will be stratified according to intensity of their cancer treatment; High intensity vs moderate/low intensity treatment regimen (ie treatment for Hodgkin lymphoma (moderate) vs treatment for sarcoma (high)). Participants will then be randomised to either immediate exercise or usual care (delayed exercise) groups. Intervention Participants randomised to the ‘immediate’ exercise intervention group will commence their exercise program the week following their baseline assessment. The exercise sessions will be conducted in a hospital based gymnasium in a one-on-one capacity. The biweekly sessions will be conducted for 10 weeks and supervised by an AEP. The baseline testing and subsequent exercise sessions will commence prior to the beginning of the second cycle of patients’ systemic treatment. The AEP will design an individual exercise program for each participant based initially on the results of the baseline functional assessment, which will then be progressed weekly as tolerated by the individual patient. Following the 10-week intervention participants, will be reassessed and then receive no intervention (usual care) for the following 10 weeks to the final assessment at 20 weeks Control (delayed exercise) Patients randomised to the ‘delayed’ exercise intervention group will receive “usual care”, and will not be offered the additional (experimental) exercise intervention for the initial 10 weeks following baseline assessment. See details below. Exercise intervention Exercise programs for all participants will be mixed mode; incorporating a combination of aerobic and resistance exercises. All programs will follow the ACSM guidelines for cancer survivors. Over the course of the program, it is expected that each participant will engage in 30 minutes of aerobic exercise and 30 minutes of resistance training within each of the two weekly supervised sessions. ACSM guidelines recommend cancer survivors complete >150 minutes of aerobic exercise per week, therefore participants will be encouraged to complete additional aerobic exercise such as walking at home to accumulate a total of 150 minutes over the week. The exercise sessions will be designed using the results of the baseline functional assessment. The aerobic exercise will be prescribed at 60-80% of Vo2peak (as determine by the CPET) and the resistance program at 50-80% of 1RM (as determine by chest press, leg press and row). Exercise intensity will be monitored using heart rate monitors and Rating of Perceived Exertion (RPE) scales. Participants will be encouraged to exercise at a moderate to high intensity (60% to 85% heart rate max). Aerobic exercise modalities will include upright/recumbent bike cycling, treadmill walking/jogging, skipping and/or boxing. The resistance exercise will comprise of an exercise for each major muscle group, with three sets of 10-15 reps per exercise. The AEP will aim to progress exercise intensity as tolerated. Participants will also be encouraged to engage in aerobic exercise outside of supervised exercise sessions through a home based aerobic exercise prescription to be completed at independently at home. They will be asked to document their activity in exercise journals. If participants fail to attend a session they will be telephoned to determine the cause of their non-adherence. Session adherence will be recorded on a weekly basis and used for reporting at the end of the intervention.

Sponsors

The University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

- Participants must be aged between 15 and 25 years of age - Diagnosed with a primary haematological malignancy or solid tumour. - Scheduled to commence or commenced systemic cancer treatment e.g. chemotherapy, radiation therapy or a combination of both within a +- 2 week period (participants who have undergone surgery will only be eligible for the trial if surgery is used in combination with chemotherapy or radiation). - Medically stable (as determined by their treating medical practitioner) with written clearance from a doctor in their treating team to undertake a progressive exercise program.

Exclusion criteria

- Cognitive impairment (determined by a medical practitioner) - Patients who undergo surgery only - <6 months life expectancy - Absolute contraindications to exercise e.g. unstable angina, uncontrolled heart failure, acute systemic infection accompanied by fever. - Insufficient English to participate in the exercise programme and exercise assessments, or to complete the questionnaire. - Pregnant or lactating.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026