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

NCT05861141 | Completed

• 1 other identifier: P.T.REC/012/004243
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Sleep Problems:

  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.

  6 months

Secondary Outcomes (4)

• Forced Vital Capacity (FVC):

  6 months

• Forced Expiratory Volume in 1 second (FEV1):

  6 months

• FEV1/FVC ratio:

  6 months

• Peak Expiratory Flow Rate (PEFR):

  6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients will receive a selected physical therapy program only.

Other: Selected physical therapy program

Study Group

EXPERIMENTAL

Patients will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training.

Device: Aerobic training

Interventions

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.

Control Group

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.

Also known as: Treadmill training

Study Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Down Syndrome; Parasomnias; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Naglaa A Zaky, PhD

  Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

• Saly S Abd Elhady, PhD

  Lecturer of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy Practitioner

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 16, 2023
• Study Start: August 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

EG (1)