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RecruitingLast updated: 26 February 2026

PROTECT: Does an exercise program help kids who are getting weaker from acute lymphoblastic leukaemia treatment build back or maintain their strength?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

Trial purpose

Medical clipboardSide effect and wellbeing

Tumor type

Blood Cancers Haematological

Age

People5 - 17

Trial acronym

PROTECT

Clinical summary

Summary

This study is a small early trial to see whether a physical activity and strengthening program is practical, acceptable, and potentially helpful for children and teenagers who have recently been diagnosed with acute lymphoblastic leukaemia (ALL).

About five weeks after diagnosis, children and young people aged 5-17 will be checked for early signs of physical weakness, sometimes called frailty. This includes looking for loss of muscle strength or muscle mass, which can help quite early during treatment. 

The study uses a new assessment approach that looks not only at muscle size (using ultrasound), but also at how the muscles work, such as grip strength, movement speed, stamina, and daily activity levels.

Children who show early signs of muscle loss will be randomly placed (by chance) into one of two groups:

  • Usual care only, or
  • Usual care plus a physical activity and strengthening program, with an activity tracker (Fitbit) to help monitor movement.

The researchers want to understand whether this type of program can be delivered easily during treatment, how families feel about it, and whether it shows early signs of benefit. The results will help design a larger future study.

Exercise is known to be safe and helpful for children, but it is usually introduced only after physical health has already declined. This study looks at whether starting earlier could help reduce the risk of ongoing weakness and fatigue.

Families can also choose whether they want to allow a blood sample to be stored for future research. This is optional and not required to take part in the main study.

Overall, the goal is to better understand why physical weakness develops during early cancer treatment and to explore ways to support children's strength, energy and everyday functioning sooner rather than later.

Conditions

This trial is treating people with newly diagnosed acute lymphoblastic leukaemia

Eligibility

Inclusion

  • Aged 5-17 years at the time of consent
  • New diagnosis of acute lymphoblastic leukaemia <7 days
  • Is planned to receive management for their cancer treatment at the trial site for the duration of the trial period
  • Has a legally acceptable representative capable of understanding the informed consent document in English and providing consent on the participant's behalf
  • Have a family electronic device that can be linked with the tool to be used (Fitbit)

Exclusion

  • none

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Murdoch Childrens Research Institute

Scientific Title

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

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