Adapted Physical Activity, Blood Cancer, Child, Only, Sleep
Conditions
Keywords
child, blood cancer, adapted physical activity, sleep, hospital and home
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.
Interventions
BEHAVIORALpractice adapted physical activity
practice daily adapted physical activity during 4 days
OTHERcontrol arm
practice once adapted physical activity during 4 days
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
experimental, randomized, cross-over, single-center therapeutic trial, controlled
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed