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

February 5, 2024 updated by: Mayar Abdel Mohsen Ahmed Magd Behairy, Cairo University
The study will be conducted to determine the effect of aerobic training on sleep problems and pulmonary functions in children with Down syndrome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Patients will receive a selected physical therapy program only.
Other: 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.
Experimental: 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.
Device: 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.

Other Names:
  • Treadmill training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC):
Time Frame: 6 months

Pulmonary Functions:

FVC will be measured by a handheld spirometer.
6 months
Forced Expiratory Volume in 1 second (FEV1):
Time Frame: 6 months

Pulmonary Functions:

FEV1 will be measured by a handheld spirometer.
6 months
FEV1/FVC ratio:
Time Frame: 6 months

Pulmonary Functions:

FEV1/FVC ratio will be measured by a handheld spirometer.
6 months
Peak Expiratory Flow Rate (PEFR):
Time Frame: 6 months

Pulmonary Functions:

PEFR will be measured by a handheld spirometer.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

May 14, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004243

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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