Clinical trial NCT05861141: Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome
Official title: Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Aerobic Training
Treadmill Training
Sleep
Sleep Problems
Sleep Disturbances
Obstructive Sleep Apnea (OSA)
Pulmonary Functions
Down Syndrome
Trisomy 21
Children's Sleep Habits Questionnaire (CSHQ)
Handheld Spirometer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sleep Problems:
timeFrame: 6 months
Secondary outcomes:
measure: Forced Vital Capacity (FVC):
timeFrame: 6 months
measure: Forced Expiratory Volume in 1 second (FEV1):
timeFrame: 6 months
measure: FEV1/FVC ratio:
timeFrame: 6 months
measure: Peak Expiratory Flow Rate (PEFR):
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
name: Naglaa A Zaky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
name: Saly S Abd Elhady, PhD
role: PRINCIPAL_INVESTIGATOR
References: