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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
practice daily adapted physical activity during 4 days
practice once adapted physical activity during 4 days
CHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGQuality of sleep
daily calendar with information about child's sleep complete by parents
Time frame: 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
Number of sleep's hour and night awakenings
wear a sleep recorder during the night
Time frame: 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
rate of daily human physical activity in met/day
wear a wearable device allday and night long
Time frame: 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
children quality of life
parent-completed questionnaire
Time frame: the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
chair stand-up test
maximum sit-up and stand-up from a chair during one minute
Time frame: 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
vigilance status description
parent-completed questionnaire
Time frame: 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
children's pain self evaluation
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self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score
Time frame: 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
fatigue status
parent-completed questionnaire
Time frame: 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
inflammation markers
C reactive protein and IL6 from daily blood test
Time frame: the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days