Exercise and activity tracking during early treatment for children with ALL to prevent muscle loss and frailty
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
This pilot test tries a home-based physical activity and strengthening program with a Fitbit for children aged 5–17 who show early muscle weakness after starting treatment for acute lymphoblastic leukaemia to see if it prevents muscle loss and improves strength compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT07325305 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are children aged 5–17 with a new diagnosis of acute lymphoblastic leukaemia treated at the trial site who, at five weeks post-diagnosis, show signs of muscle weakness or frailty and have a caregiver with an electronic device that can link to a Fitbit.
Not a fit: Children who do not show early muscle loss are only monitored and will not receive the exercise intervention, so they are unlikely to gain direct benefit from the trial intervention.
Why it matters
Potential benefit: If successful, the intervention could help preserve or restore muscle mass and strength early in ALL treatment, reducing frailty and improving recovery.
How similar studies have performed: Exercise is known to be safe and beneficial for children in general, but proactive early exercise interventions to prevent sarcopenia during initial ALL treatment are novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Melbourne, Victoria
- Royal Children's Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Sarah Grimshaw, PhD Physiotherapy
- Email: sarah.grimshaw@mcri.edu.au
- Phone: +61417162166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.