Clinical trial · Interventional
Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia
Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing 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 will be the first multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 4- \<19 years) with newly diagnosed ALL. It will test the ability of the intervention to prevent or diminish early physical function limitations and improve health-related quality of life (HRQL). The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo "minimal movement" standard care strategy).
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Therapy | Behavioral | — | UNRESOLVED |
| Support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Minimal movement
- description
- Minimal movement group with usual care non-intervention.
- type
- ACTIVE_COMPARATOR
- label
- Physical Therapy
- interventionNames
- Behavioral: Physical Therapy
- Behavioral: Support
Primary outcomes (1)
- measure
- Bone Mineral Density/Bone Mineral Content
- timeFrame
- Assessed at baseline and at completion of therapy
Secondary outcomes (1)
- measure
- Health- related quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. An immunophenotypic diagnosis of non-B cell ALL 2. Age 4 years through \<19 years at diagnosis 3. 2-8 days on or per front line ALL treatment protocol 4. One parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the English Language 5. Participant speaks and understands the English language 6. Written informed consent and child assent Exclusion Criteria: 1. Age \< 4 years or ≥19 years at diagnosis 2. A diagnosis of cerebral palsy or down syndrome 3. Second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency 4. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent 5. Females who are pregnant.
References
Publications (1)
- DERIVEDNess KK, Kaste SC, Zhu L, Pui CH, Jeha S, Nathan PC, Inaba H, Wasilewski-Masker K, Shah D, Wells RJ, Karlage RE, Robison LL, Cox CL. Skeletal, neuromuscular and fitness impairments among children with newly diagnosed acute lymphoblastic leukemia. Leuk Lymphoma. 2015 Apr;56(4):1004-11. doi: 10.3109/10428194.2014.944519. Epub 2014 Aug 20. PMID 25030039