Exercise and activity tracking during early treatment for children with ALL to prevent muscle loss and frailty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot randomized controlled trial with a hybrid implementation design carried out at a single pediatric centre. At five weeks after diagnosis, children aged 5–17 are screened for signs of frailty and sarcopenia; those who screen positive are randomized to standard care or to a physical activity and strengthening program combined with activity tracking using a Fitbit. Children who do not show muscle loss are followed observationally to document natural recovery. The study will measure feasibility, acceptability, preliminary signals of efficacy, and variability of outcome measures to inform a larger definitive trial; optional blood sampling may be requested for mechanistic studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* none

Where it's running

• Royal Children's Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Sarah Grimshaw, PhD Physiotherapy
• Email: sarah.grimshaw@mcri.edu.au
• Phone: +61417162166

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Lower-limb rehabilitation robot training with nutrition education for sarcopenia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.