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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quality of sleep
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of sleep
时间窗: 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
次要结局
- 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)
- children quality of life(the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days)
- 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)
- 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)
- 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)
- 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)
- 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)
- inflammation markers(the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days)