Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome
- Conditions
- Down Syndrome
- Interventions
- Other: Selected physical therapy programDevice: Aerobic training
- Registration Number
- NCT05861141
- Lead Sponsor
- Cairo University
- Brief Summary
The study will be conducted to determine the effect of aerobic training on sleep problems and pulmonary functions in children with Down syndrome.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Selected physical therapy program Patients will receive a selected physical therapy program only. Study Group Aerobic training Patients will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training.
- Primary Outcome Measures
Name Time Method Sleep Problems: 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.
- Secondary Outcome Measures
Name Time Method Peak Expiratory Flow Rate (PEFR): 6 months Pulmonary Functions:
PEFR will be measured by a handheld spirometer.Forced Expiratory Volume in 1 second (FEV1): 6 months Pulmonary Functions:
FEV1 will be measured by a handheld spirometer.Forced Vital Capacity (FVC): 6 months Pulmonary Functions:
FVC will be measured by a handheld spirometer.FEV1/FVC ratio: 6 months Pulmonary Functions:
FEV1/FVC ratio will be measured by a handheld spirometer.
Trial Locations
- Locations (1)
Cairo University
🇪🇬Cairo, Egypt