RecruitingNot ApplicableNCT07325305

Physical Activity and Exercise During Early Treatment Phases for Childhood Acute Lymphoblastic Leukaemia to Protect Against Muscle Loss and Improve Frailty Outcomes

The PROTECT Trial Physical Activity and Exercise During Early Treatment for Children With Acute Lymphoblastic Leukaemia to Protect Against Sarcopenia and Improve Frailty Outcomes: a Pilot Randomised Controlled Trial


Sponsor

Murdoch Childrens Research Institute

Enrollment

60 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a small trial testing out a new approach before doing a bigger study. Researchers are observing a group of children/adolescents (ages 5-17) with acute lymphoblastic leukemia (ALL) and testing a physical activity and exercise program on a group of them who after 5 weeks of treatment show signs of weakness or frailty. Kids who are NOT losing muscle aren't part of the exercise trial - they're just monitored over time to see how they do. The goal: To see if an exercise program helps kids who are getting weaker from acute lymphoblastic leukemia treatment build back/maintain their strength, compared to kids who don't do the extra intervention. The study will also look at if this way of measuring muscle weakness works well for kids with cancer.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a structured physical activity and exercise program for children newly diagnosed with acute lymphoblastic leukemia (ALL) — the most common childhood cancer — to see if staying active during the early, intense phase of chemotherapy can prevent muscle loss and reduce physical frailty. **You may be eligible if...** - Your child is 5–17 years old - Your child was diagnosed with acute lymphoblastic leukemia within the last 7 days - Your child will receive their cancer treatment at the study hospital - Your family has a compatible electronic device (for the Fitbit activity tracker) - A parent or legal guardian can provide consent in English **You may NOT be eligible if...** - There are no specific exclusion criteria for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExercise

These participants demonstrated early signs of sarcopenia at the post induction phase of treatment assessment point and were randomised to the intervention group. The intervention group receives 9 weeks of goal setting and physical activity behaviour change coaching (with activity tracking via Fitbit for continuous feedback) as well as concurrent 8 weeks of 3x45-60 minute structured exercise sessions weekly. These are individualised based on their functional performance outcomes from the assessment prior to randomisation with a resistance strength training and progressive overload principles. The delivery of the specific exercises will be based on a pragmatic, participation based focus and will incorporate the individuals development stage, age, interests and enjoyment.


Locations(1)

Royal Children's Hospital

Melbourne, Victoria, Australia

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NCT07325305


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