Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years
- Conditions
- Blood CancerAdapted Physical ActivitySleepChild, Only
- Interventions
- Other: control armBehavioral: practice adapted physical activity
- Registration Number
- NCT06455592
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description standard control arm practice only once adapted physical activity in hospital and at home during four days daily adapted physical activity practice adapted physical activity practice adapted physical activity daily in hospital and at home during four days
- Primary Outcome Measures
Name Time Method Quality of sleep 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 daily calendar with information about child's sleep complete by parents
- Secondary Outcome Measures
Name Time Method rate of daily human physical activity in met/day 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 wear a wearable device allday and night long
children quality of life the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days parent-completed questionnaire
vigilance status description 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 parent-completed questionnaire
children's pain self evaluation 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 self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score
fatigue status 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 parent-completed questionnaire
Number of sleep's hour and night awakenings 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 wear a sleep recorder during the night
chair stand-up test 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 maximum sit-up and stand-up from a chair during one minute
inflammation markers the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days C reactive protein and IL6 from daily blood test
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France