Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sleep Problems:
研究概览
简要总结
The study will be conducted to determine the effect of aerobic training on sleep problems and pulmonary functions in children with Down syndrome.
详细描述
The study will be carried out on 30 children with Down syndrome (trisomy 21) of both sexes, with ages ranging from 7 to 12 years old. Children will be recruited from schools for children with special needs. Children will be randomly assigned into two equal groups (control and study groups), 15 for each group. The control group will receive a selected physical therapy program only, while the study group will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training. The Arabic version of the Children's Sleep Habits Questionnaire (CSHQ) will be used to assess sleep problems, while a handheld spirometer will be used to assess pulmonary functions (forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC ratio, and peak expiratory flow rate (PEFR)) pre- and post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with Down syndrome (trisomy 21).
- •Their ages range from 7 to 12 years old.
- •Both sexes will be included.
- •Children should be able to understand and follow simple verbal commands or instructions (intelligence quotient (IQ) range: 50-70).
- •Children should be able to walk independently.
- •Their total scores on the Arabic version of the Children's Sleep Habits Questionnaire (CSHQ) equal 41 or higher.
排除标准
- •Children will be excluded from the study if they:
- •Have visual or hearing defects.
- •Have spinal abnormality such as kyphosis and scoliosis.
- •Have history of pulmonary infection and surgery of thoracic and abdominal region within the past 6 months.
- •Play any specific sport or exercises.
- •Have physical activity restrictions.
- •Have musculoskeletal disorder.
- •Take medications known to affect sleep.
结局指标
主要结局
Sleep Problems:
时间窗: 6 months
Will be measured by the Arabic version of the Children's Sleep Habits Questionnaire (CSHQ): A 33-item retrospective parent-report questionnaire was created as a screening tool for sleep issues over a "typical" recent week. Each item is scored 1-3 (1 = Rarely, 0-1x/week; 2 = Sometimes, 2-4x/week; 3 = Usually, 5-7x/week). There are 6 questions with reverse scoring in order to consistently make a higher score indicative of more disrupted sleep. This will yield a total score between 33 and 99. A total score of 41 or higher suggests the presence of a sleep disturbance.
次要结局
- Peak Expiratory Flow Rate (PEFR):(6 months)
- Forced Expiratory Volume in 1 second (FEV1):(6 months)
- Forced Vital Capacity (FVC):(6 months)
- FEV1/FVC ratio:(6 months)
研究者
Mayar Abdel Mohsen Ahmed Magd Behairy
Physiotherapy Practitioner
Cairo University