Down SyndromeNCT05861141
Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome
A study testing Selected physical therapy program and Aerobic training in people with Down Syndrome, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Selected physical therapy program and Aerobic training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The study will be conducted to determine the effect of aerobic training on sleep problems and pulmonary functions in children with Down syndrome.
Read the 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
- Being tested
- Selected physical therapy program, Aerobic training
- 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
- Medical subject headings
- Down Syndrome, Parasomnias, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected physical therapy programOther
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.
Aerobic trainingDevice
Also called Treadmill 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients will receive a selected physical therapy program only. Receives: Other: Selected physical therapy program |
| Study Group | Experimental | Patients will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training. Receives: Device: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Forced Vital Capacity (FVC):
Pulmonary Functions:
FVC will be measured by a handheld spirometer.
Measured: 6 months
Forced Expiratory Volume in 1 second (FEV1):
Pulmonary Functions:
FEV1 will be measured by a handheld spirometer.
Measured: 6 months
FEV1/FVC ratio:
Pulmonary Functions:
FEV1/FVC ratio will be measured by a handheld spirometer.
Measured: 6 months
Peak Expiratory Flow Rate (PEFR):
Pulmonary Functions:
PEFR will be measured by a handheld spirometer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Aug 2023
- Primary completion31 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayar Abdel Mohsen Ahmed Magd Behairy, Cairo University
- Investigators
- Naglaa A Zaky, PhD, Principal investigator, Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo UniversitySaly S Abd Elhady, PhD, Principal investigator, Lecturer of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861141
- Sponsor's protocol ID
- P.T.REC/012/004243
- Status last verified
- Jun 2025
- First submitted
- 5 Apr 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Training on Sleep Problems and Pulmonary Functions in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05861141
- Acronym / sponsor ID
- P.T.REC/012/004243
- Conditions
- Down Syndrome
- Keywords
- Aerobic Training, Treadmill Training, Sleep, Sleep Problems, Sleep Disturbances, Obstructive Sleep Apnea (OSA), Pulmonary Functions, Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Selected physical therapy programPatients will receive a selected physical therapy program only. |
| Study Group | Experimental | Device: Aerobic trainingPatients will receive the same selected physical therapy program as the control group in addition to aerobic exercise in the form of treadmill training. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selected physical therapy programPatients 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. | Other | Control Group |
| Aerobic trainingAlso: Treadmill trainingPatients 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. | Device | Study Group |
Primary outcome
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.
4 secondary outcomes
Forced Vital Capacity (FVC):
Time frame: 6 months
Forced Expiratory Volume in 1 second (FEV1):
Time frame: 6 months
FEV1/FVC ratio:
Time frame: 6 months
Peak Expiratory Flow Rate (PEFR):
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naglaa A Zaky, PhD principal investigator
Professor of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Saly S Abd Elhady, PhD principal investigator
Lecturer of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selected physical therapy program and Aerobic training in people with Down Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Problems: (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.