Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Observation cohort
- description
- These participants did not have early signs of sarcopenia at the post induction therapy assessment point, but will be followed up at all timepoints to better understand the natural progression of acute lymphoblastic leukaemia. Usual care is a ward based physiotherapist service which is reactive and referral based only.
- type
- NO_INTERVENTION
- label
- Usual care control group
- description
- These participants demonstrated early signs of sarcopenia at the post induction phase of treatment assessment point and were randomised to the control group. Usual care is a ward based physiotherapist service which is reactive and referral based only.
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- These participants demonstrated early signs of sarcopenia at the post induction phase of treatment assessment point and were randomised to the intervention group. The intervention group receives 9 weeks of goal setting and physical activity behaviour change coaching, as well as concurrently receiving 8 weeks of structured exercise sessions weekly (\~40 minute sessions x 3/week). These sessions are individualised based on the participant's functional performance outcomes from the assessment prior to randomisation, with a resistance strength training and progressive overload principles. The delivery of the specific exercises will be based on a pragmatic, participation based focus and will incorporate the individual's development stage, age, interests and enjoyment. A second component will be delivered throughout the trial via staff driven solutions which address commonly identifed environmental and organisational barriers to physical activity for children throughout the trial.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available