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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Patients will receive a selected physical therapy program only. |
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| Study Group | Experimental | Patients will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selected physical therapy program | Other | Patients will receive a selected physical therapy program for 1 hr, 3 times per week, for 3 successive months in the form of:
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Children will be excluded from the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Naglaa A Zaky, PhD | Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University | Principal Investigator |
| Saly S Abd Elhady, PhD | Lecturer of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D020447 | Parasomnias |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Aerobic training | Device | 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. |
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| 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 |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |