CHU de Clermont-Ferrand
Clermont-Ferrand, France
Location status: Recruiting
Location contact
Emmanuelle LABRAISE
PRINCIPAL_INVESTIGATOR
Lise Laclautre
CONTACT
NCT Number: NCT06455592
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
Interested in participating?
Request Info5 year–16 year
All sexes
Interventional
Not applicable
Clermont-Ferrand, France
Location status: Recruiting
Emmanuelle LABRAISE
PRINCIPAL_INVESTIGATOR
Lise Laclautre
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
practice daily adapted physical activity during 4 days
practice once adapted physical activity during 4 days
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
daily calendar with information about child's sleep complete by parents
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
wear a sleep recorder during the night
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
wear a wearable device allday and night long
Time frame: the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
parent-completed questionnaire
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
maximum sit-up and stand-up from a chair during one minute
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
parent-completed questionnaire
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
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 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
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.
Acronym: APANYX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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