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NCT07325305Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
18 Dec 2025
Start date
24 Feb 2026
Primary completion date
17 Jul 2028
Lead sponsor
Murdoch Childrens Research Institute
NCT number
NCT07325305

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 24 Feb 2026 to the primary completion date, 17 Jul 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • none

Who the study is looking for

  • 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)

Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Children's Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.