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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02575-40 | Other Identifier | 2023-A02575-40 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard | Active Comparator | practice only once adapted physical activity in hospital and at home during four days |
|
| daily adapted physical activity | Experimental | practice adapted physical activity daily in hospital and at home during four days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| practice adapted physical activity | Behavioral | practice daily adapted physical activity during 4 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of sleep | daily calendar with information about child's sleep complete by parents | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sleep's hour and night awakenings | wear a sleep recorder during the night | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuelle LABRAISE | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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experimental, randomized, cross-over, single-center therapeutic trial, controlled
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| control arm | Other | practice once adapted physical activity during 4 days |
|
wear a wearable device allday and night long |
| 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 | 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 | 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 | 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 | self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score | 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 | 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 | the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |