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A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment in adolescents and young adults

A pilot randomised controlled trial of a structured exercise intervention after the completion of cancer treatment in adolescents and young adults

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000527561
Acronym
YCS ET1
Enrollment
40
Registered
2015-05-26
Start date
2015-04-13
Completion date
2016-12-30
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This pilot trial aims to evaluate if a structured exercise intervention improves fitness, lowers fatigue and improves quality of life in adolescents and young adults after the completion of cancer treatment. Who is it for? You may be eligible to join this study if you are aged between 15 and 25 years of age, are diagnosed with a haematological malignancy or solid tumour and have completed a systemic cancer treatment (ie chemotherapy and/or radiotherapy). Study details: Participants in this study will be assigned to either an intervention group or the control group by chance. Participants in the intervention group will receive 10 weeks of structured, individually tailored exercise intervention performed twice a week for 60 min per session. The control group will not receive exercise physiology input and will not be offered an exercise intervention during the study period; however no restrictions will be imposed on their activities. (Once the study is over, control patients will be offered participation in an exercise intervention if they want, but this will not be part of the study). Participants in both groups will have a blinded assessment of physical fitness, fatigue, and quality of life at baseline, 10 weeks, and 6 months. These measures will be compared between the group undertaking the programme and the control arm to determine whether the programme is associated with initial improvements, and whether these improvements are sustained at 6 months. It is hoped that this study will help determine whether a structured exercise programme speeds up recovery of physical fitness, reduces fatigue, and improves quality of life in adolescent and young adult patients who have been treated for cancer.

Interventions

Subjects randomised to the intervention arm will receive a 10-week intensive exercise programme from an exercise physiologist. Specifically, they will be asked to attend two supervised gym or home-based exercise sessions per week for 10 weeks. An Exercise Physiologist will design an individual exercise prescription for each participant based on results from the baseline functional assessments. Exercise will be mixed mode and will incorporate a combination of aerobic and resistance exercises. Exe

Subjects randomised to the intervention arm will receive a 10-week intensive exercise programme from an exercise physiologist. Specifically, they will be asked to attend two supervised gym or home-based exercise sessions per week for 10 weeks. An Exercise Physiologist will design an individual exercise prescription for each participant based on results from the baseline functional assessments. Exercise will be mixed mode and will incorporate a combination of aerobic and resistance exercises. Exercises to improve flexibility will be included at the end of each exercise session. Exercise sessions will last no longer than 60 minutes. Over time it is expected that each participant will engage in 30 minutes of aerobic exercise and 30 minutes of resistance training, plus flexibility exercises. Exercise intensity will be monitored using heart rate monitors and participants will be encouraged to exercise at a moderate to high intensity (60% to 85% heart rate max). The Exercise Physiologist will aim to progress exercise intensity as tolerated. Participants will also be encouraged to engage in aerobic exercise outside of supervised exercise sessions. Participants will also be provided with informal education sessions on the importance of exercise post cancer therapy. Parents and/or partners of participants will also be invited and encouraged to attend education sessions regarding the importance of physical activity and exercise post treatment.

Sponsors

Australian and New Zealand Children's Haematology and Oncology Group
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

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 haematological malignancy or solid tumour - Completed systemic cancer treatment e.g. chemotherapy, radiation therapy or a combination of both (participants who have undergone surgery will only be eligible for the trial if surgery is used in combination with chemotherapy or radiation). - Cancer therapy completed within the previous two months (or have started maintenance therapy for acute lymphoblastic leukaemia (or lymphoblastic lymphoma) within the past two months) - Medically stable (as determined by a medical practitioner) and 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 questionnaires

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026