Aerobic training's effects on sleep and lung function in children with Down syndrome
Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome
This study is testing if adding treadmill exercises to regular physical therapy can help improve sleep and lung function in children with Down syndrome aged 7 to 12.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05861141 on ClinicalTrials.gov |
What this trial studies
This study investigates how aerobic training, specifically treadmill exercises, impacts sleep problems and pulmonary functions in children aged 7 to 12 with Down syndrome. A total of 30 children will be randomly divided into two groups: one receiving a standard physical therapy program and the other receiving the same program plus aerobic training. Sleep issues will be assessed using the Arabic version of the Children's Sleep Habits Questionnaire, while pulmonary functions will be measured with a handheld spirometer before and after the intervention. The goal is to determine if aerobic exercise can improve both sleep quality and lung function in this population.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 12 with Down syndrome who can follow simple instructions and walk independently.
Not a fit: Patients with visual or hearing defects, spinal abnormalities, recent pulmonary infections, or those on medications affecting sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and respiratory health in children with Down syndrome.
How similar studies have performed: While there is limited research specifically on aerobic training in this demographic, similar interventions have shown positive outcomes in improving sleep and pulmonary functions in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Naglaa A Zaky, PhD — Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
- Study coordinator: Mayar A Behairy, B.Sc.
- Email: pt.mayar2018.2019@gmail.com
- Phone: 01144209907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.