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Completed

NCT Number: NCT05861141

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

The study will be conducted to determine the effect of aerobic training on sleep problems and pulmonary functions in children with Down syndrome.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Apnea Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Genetic Diseases, Inborn Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Parasomnias Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • 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.

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.

Other names: Treadmill training

Primary outcomes

  1. Sleep Problems:

    Time frame: 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 outcomes

  1. Forced Vital Capacity (FVC):

    Time frame: 6 months

    Pulmonary Functions:

    FVC will be measured by a handheld spirometer.

  2. Forced Expiratory Volume in 1 second (FEV1):

    Time frame: 6 months

    Pulmonary Functions:

    FEV1 will be measured by a handheld spirometer.

  3. FEV1/FVC ratio:

    Time frame: 6 months

    Pulmonary Functions:

    FEV1/FVC ratio will be measured by a handheld spirometer.

  4. Peak Expiratory Flow Rate (PEFR):

    Time frame: 6 months

    Pulmonary Functions:

    PEFR will be measured by a handheld spirometer.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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