NCT05861141

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
OTHER	Selected physical therapy program	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.
DEVICE	Aerobic training	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-03-31
• Completion: 2024-05-31
• First posted: 2023-05-16
• Last updated: 2025-06-04

Locations

1 site across 1 country: Egypt