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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05861141

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Other: Selected physical therapy program Device: Aerobic training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sleep Problems: [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.

Secondary Outcome Measures

Forced Vital Capacity (FVC): [6 months]
Pulmonary Functions: FVC will be measured by a handheld spirometer.
Forced Expiratory Volume in 1 second (FEV1): [6 months]
Pulmonary Functions: FEV1 will be measured by a handheld spirometer.
FEV1/FVC ratio: [6 months]
Pulmonary Functions: FEV1/FVC ratio will be measured by a handheld spirometer.
Peak Expiratory Flow Rate (PEFR): [6 months]
Pulmonary Functions: PEFR will be measured by a handheld spirometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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