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Clinical Trials/NCT05861141
NCT05861141
Completed
Not Applicable

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

Cairo University1 site in 1 country30 target enrollmentAugust 1, 2023
ConditionsDown Syndrome

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Down Syndrome
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
Sleep Problems:
Status
Completed
Last Updated
11 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
May 31, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mayar Abdel Mohsen Ahmed Magd Behairy

Physiotherapy Practitioner

Cairo University

Eligibility 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.

Outcomes

Primary Outcomes

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

  • Peak Expiratory Flow Rate (PEFR):(6 months)
  • Forced Expiratory Volume in 1 second (FEV1):(6 months)
  • Forced Vital Capacity (FVC):(6 months)
  • FEV1/FVC ratio:(6 months)

Study Sites (1)

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