Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome

Study Overview
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Brief Summary
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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
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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 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.

Official Title
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Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome

Conditions
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Down Syndrome

Intervention / Treatment
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* Other: Selected physical therapy program
* Device: Aerobic training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Patients will receive a selected physical therapy program only. | Other: Selected physical therapy program<br>* Patients will receive a selected physical therapy program for 1 hr, 3 times per week, for 3 successive months in the form of: Balance and postural control exercises for 15 minutes, including the following: Standing on balance board. Stoop and recovery. Gait training for 45 minutes, including the following: Forward, backward, and sideways walking. Walking with obstacles using wedges and rolls with different diameters and heights.<br>|
| Experimental: Study Group<br>Patients will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training. | Device: Aerobic training<br>* Patients will receive the same selected physical therapy program as the control group for 15 minutes in addition to treadmill training for 45 minutes, 3 times per week, for 3 successive months. Treadmill training: Will be practiced according to the following stages: A- Warm up: 5 minutes. B- The exercise phase: 35 minutes (three-minute stages), the speed will be increased gradually every 3 minutes intervals until the child no longer be able to walk at the current stage. C- Cool down: 5 minutes.<br>* Other names: Treadmill training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Problems: | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Vital Capacity (FVC): | Pulmonary Functions: FVC will be measured by a handheld spirometer. | 6 months | 
| Forced Expiratory Volume in 1 second (FEV1): | Pulmonary Functions: FEV1 will be measured by a handheld spirometer. | 6 months | 
| FEV1/FVC ratio: | Pulmonary Functions: FEV1/FVC ratio will be measured by a handheld spirometer. | 6 months | 
| Peak Expiratory Flow Rate (PEFR): | Pulmonary Functions: PEFR will be measured by a handheld spirometer. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treadmill Training, Aerobic Training, Sleep, Sleep Problems, Sleep Disturbances, Obstructive Sleep Apnea (OSA), Pulmonary Functions, Down Syndrome, Trisomy 21, Children's Sleep Habits Questionnaire (CSHQ), Handheld Spirometer