Daily adapted physical activity to improve sleep in children 5–16 with blood cancer
Effect of Practicing Adapted Physical Activity (APA) on Sleep Quality in Children From 5 Years of Age and Adolescents up to 16 Years of Age Undergoing Treatment for a Hematologic Malignancy.
This trial will see if doing adapted physical activity every day instead of only once over four days improves sleep for children aged 5–16 who are receiving treatment for blood cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 5 Years to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06455592 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, open-label crossover trial at CHU de Clermont-Ferrand compares two adapted physical activity schedules to see effects on sleep in children aged 5–16 undergoing treatment for blood cancers. Participants are randomized to a conventional schedule (one adapted physical activity session over four days) or an experimental schedule (daily adapted physical activity for four days), with the study lasting four weeks and including a one-week washout after two weeks. Interventions are delivered at the hospital and continued at home as applicable, with consent obtained from parents and children. Sleep outcomes in the two arms will be compared after statistical analysis to determine the effect of daily adapted physical activity on sleep.
Who should consider this trial
Good fit: Children aged 5–16 who are receiving treatment for hematological (blood) cancer, are enrolled in the Social Security system, and whose parents and they provide informed consent are ideal candidates.
Not a fit: Children on high‑dose corticosteroids, taking anxiolytics, melatonin or other sleeping pills, with sleep apnea, or with contraindications to adapted physical activity are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, daily adapted physical activity could improve sleep quality and overall well-being for children undergoing treatment for blood cancer.
How similar studies have performed: Physical activity has been shown to improve sleep in other pediatric and adult populations, but daily adapted activity during active pediatric cancer treatment has been less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children from 5 to 16 with haematological cancer undergoing treatment * Subjects and their parents who were informed about the study and gave informed consent. * Enrollment in the Social Security system Exclusion Criteria: * Children on high-dose corticosteroids * Children under anxiolytic treatment * Children with sleep disorders (sleep apnea) * Children taking melatonin or sleeping pills * Contraindication to adapted physical activity * Refusal to participate on the part of the participant or his/her parents * Holders of parental authority under curatorship, guardianship, safeguard of justice * Pregnant or breast-feeding teenagers
Where this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Emmanuelle LABRAISE — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
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.