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

NCT ID: NCT05861141

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-05-31

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.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Patients will receive a selected physical therapy program only.

Group Type: ACTIVE_COMPARATOR

Selected physical therapy program

Intervention Type: 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.

Study Group

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

Group Type: EXPERIMENTAL

Aerobic training

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

Treadmill training

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mayar Abdel Mohsen Ahmed Magd Behairy

Physiotherapy Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naglaa A Zaky, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Saly S Abd Elhady, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004243

Identifier Type: -

Identifier Source: org_study_id