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

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861141
• Other study ID #: P.T.REC/012/004243
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Mayar A Behairy, B.Sc.
• Phone: 01144209907
• Email: pt.mayar2018.2019[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be conducted to determine the effect of aerobic training on sleep problems and pulmonary functions in children with Down syndrome.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Down Syndrome
• Dyssomnias
• Parasomnias
• Syndrome

Intervention

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.

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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Forced Vital Capacity (FVC):	Pulmonary Functions: FVC will be measured by a handheld spirometer.	6 months
Secondary	Forced Expiratory Volume in 1 second (FEV1):	Pulmonary Functions: FEV1 will be measured by a handheld spirometer.	6 months
Secondary	FEV1/FVC ratio:	Pulmonary Functions: FEV1/FVC ratio will be measured by a handheld spirometer.	6 months
Secondary	Peak Expiratory Flow Rate (PEFR):	Pulmonary Functions: PEFR will be measured by a handheld spirometer.	6 months