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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Children's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.