Clinical trial NCT06455592: Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child, Only
Blood Cancer
Adapted Physical Activity
Sleep
Keywords: child
blood cancer
adapted physical activity
sleep
hospital and home
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: experimental, randomized, cross-over, single-center therapeutic trial, controlled
Primary purpose: PREVENTION

Brief summary: Main objective :

Evaluate the effect of adapted physical activity on the sleep of children with cancer from 5 to 16

Hypothesis :

Practice daily adapted physical activity improve the sleep of the 5 to 16 children with cancer

Detailed description: Medical process are leading to an increase in the survival of children/adolescents undergoing treatment for blood cancer. Caregivers need to focus on optimizing these patients' quality of life during and after the disease. Sleep is essential to their development. Sleep disorders are symptoms reported by patients. They have a negative impact on their quality of life. Adapted physical activity sessions are offered in pediatric oncology departments, but sedentary behavior persists. The hypothesis is that the daily practice of adapted physical activity will improve sleep in patients treated for blood cancer.

This is a randomized, cross-over, open-label, two-armed parallel, unique center therapeutic trial comparing the effect of practice adapted physical activity only once during four days (conventional strategy) versus practice adapted physical activity each day during four days (experimental strategy) on the sleep of the children with blood cancer from 5 to 16 at the hospital in Clermont-Ferrand and at home.

The study will last four weeks with a wash-out week after 2 weeks. The outcomes are described later. The nurse informs and obtains the consent of the child and his parents. After statistical analysis of these two arms, it will be possible to determine the value of practice daily adapted physical activity on the sleep of children with blood cancer from 5 to 16 at the hospital and at home.

Eligibility 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

Primary outcomes:
measure: Quality of sleep
timeFrame: the morning and the evening, from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
Secondary outcomes:
measure: Number of sleep's hour and night awakenings
timeFrame: Each night from the bedtime to the wake up time, from the bedtime of the first day to the wake up time of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
measure: rate of daily human physical activity in met/day
timeFrame: from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
measure: children quality of life
timeFrame: the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
measure: chair stand-up test
timeFrame: the morning of the first day and the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
measure: vigilance status description
timeFrame: at 10am, 2pm and 6pm from the first day to the third day and only at 10am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
measure: children's pain self evaluation
timeFrame: at 8am and 6pm from the first day to the third day and only at 8am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
measure: fatigue status
timeFrame: at 10am, 2pm and 6pm from the first day to the third day and only at 10am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
measure: inflammation markers
timeFrame: the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuelle LABRAISE
role: PRINCIPAL_INVESTIGATOR
References: