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

Primary Purpose

Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Selected physical therapy program
Aerobic training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring 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

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Study Group

Arm Description

Patients will receive a selected physical therapy program only.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Forced Vital Capacity (FVC):
Pulmonary Functions: FVC will be measured by a handheld spirometer.
Forced Expiratory Volume in 1 second (FEV1):
Pulmonary Functions: FEV1 will be measured by a handheld spirometer.
FEV1/FVC ratio:
Pulmonary Functions: FEV1/FVC ratio will be measured by a handheld spirometer.
Peak Expiratory Flow Rate (PEFR):
Pulmonary Functions: PEFR will be measured by a handheld spirometer.

Full Information

First Posted
April 5, 2023
Last Updated
September 26, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05861141
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients will receive a selected physical therapy program only.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Patients will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training.
Intervention Type
Other
Intervention Name(s)
Selected physical therapy program
Intervention Description
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
Device
Intervention Name(s)
Aerobic training
Other Intervention Name(s)
Treadmill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep Problems:
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Forced Vital Capacity (FVC):
Description
Pulmonary Functions: FVC will be measured by a handheld spirometer.
Time Frame
6 months
Title
Forced Expiratory Volume in 1 second (FEV1):
Description
Pulmonary Functions: FEV1 will be measured by a handheld spirometer.
Time Frame
6 months
Title
FEV1/FVC ratio:
Description
Pulmonary Functions: FEV1/FVC ratio will be measured by a handheld spirometer.
Time Frame
6 months
Title
Peak Expiratory Flow Rate (PEFR):
Description
Pulmonary Functions: PEFR will be measured by a handheld spirometer.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mayar A Behairy, B.Sc.
Phone
01144209907
Email
pt.mayar2018.2019@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naglaa A Zaky, PhD
Organizational Affiliation
Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saly S Abd Elhady, PhD
Organizational Affiliation
Lecturer of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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