Down Syndrome (DS)NCT07328165
The Impact of Core Stability Versus Respiratory Muscle Strengthening Exercises on Bone Mineral Density in Children With Down Syndrome
A study testing Core Stability Exercise Group and Respiratory Muscle Strengthening Group in people with Down Syndrome (DS) and Low Bone Mineral Density, run by Cairo University at 1 site in Egypt.
Trial summary
Children with Down syndrome often exhibit diminished physical fitness levels and lower bone mass. Numerous factors contribute to this decrease in bone mass density, including decreased levels of leptin, reduced muscle mass and strength, impaired balance, and skeletal abnormalities. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Down Syndrome (DS), Low Bone Mineral Density
- What is being tested?
- Core Stability Exercise Group and Respiratory Muscle Strengthening Group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age will range from 10-13 years
- Diagnosed with Down syndrome.
- Children with the ability to understand and follow verbal commands and instructions used during training and tests
- Able to stand and walk independently
Who cannot join
- Any neurological, mobility disorders, vision or hearing loss, cardiac anomalies or musculoskeletal disorder
- With asthma or any chronic chest diseases
- With significant tightness or deformities in the lower limbs and limber spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Core Stability vs Respiratory Muscle Training in Children With Down Syndrome
Children with Down syndrome often exhibit diminished physical fitness levels and lower bone mass. Numerous factors contribute to this decrease in bone mass density, including decreased levels of leptin, reduced muscle mass and strength, impaired balance, and skeletal abnormalities. These factors further exacerbate the risk of developing osteoporosis in this population. Therefore, it is crucial to prioritize interventions that focus on maximizing peak bone mass during childhood in order to enhance the quality of life for adults with Down syndrome. The study aims to compare the impact of core stability exercises and respiratory muscle strengthening exercises on bone mineral density in children with Down syndrome. Sixty Children with Down syndrome will be assessed and included in this study. The age of children will range from 10 to 13 years. Children will be allocated randomly into three groups (control and two study group A \& B). The control group receives a physical therapy program, study group A receives traditional physical therapy program with core stability exercises, and study group B receives traditional physical therapy program with respiratory muscle strengthening exercises. Groups will be evaluated using dual energy X-ray absorptiometry DXA (DPX-IQ, version 4.6A). Bone mineral density (BMD) of femoral neck and lumbar spine will be determined and the mean density will be expressed as g/cm2.
- Conditions
- Down Syndrome (DS), Low Bone Mineral Density
- Being tested
- Core Stability Exercise Group, Respiratory Muscle Strengthening Group, Control /Conventional Physiotherapy Group
- Medical subject headings
- Down Syndrome, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stability Exercise GroupBehavioural
Based on Jeffrey's protocol, the protocol includes specific spinal stabilization exercises, lumbar-pelvic proprioception retraining, and abdominal maneuvers (holding the abdomen in) and multifidus muscle contraction, followed by maintaining stabilization maneuver using dynamic stability achieved in different positions (supine, prone, and squatting) and addition of dynamic elements (limb movement, use of Swiss ball) in later stages.
Respiratory Muscle Strengthening GroupDevice
By using a threshold inspiratory muscle training (IMT) (Respironics, Cedar Grove, NJ, USA). Frequency 3 time per week for 8 weeks. It is a spring-loaded valve that inspiratory resistance can be adjusted. This training last for 30 min. To develop muscle strength; during the first 10 min of practice, threshold IMT will be used in 10 series of 60s each, separated by rest periods of 60s. To develop endurance; during the final 20 min, the equipment will be used uninterruptedly. Prior to the beginning of each session, the pressure threshold load throughout the practice will be 50 % of Maximum Inspiratory pressure that will be calculated during the evaluation of children.
Control /Conventional Physiotherapy GroupBehavioural
The primary focus of the program was to improve bone mineral density. Each session will be conducted 60 minutes and consist of weight bearing exercises and strengthen exercises in the form of isometric exercises;
| Study group | Role | What they receive |
|---|---|---|
| Core Stability Exercise Group | Experimental | This group will receive core stability exercises in addition to physical therapy program as control group. Receives: Behavioral: Core Stability Exercise Group |
| Respiratory Muscle Strengthening Group | Experimental | This group will receive respiratory muscle strengthening exercises in addition to physical therapy program as control group Receives: Device: Respiratory Muscle Strengthening Group |
| Control Group | Active comparator | The control group will receive the physical therapy program and conduct three times peer week over 8 consecutive weeks under the supervision of a physical rehabilitation specialist Receives: Behavioral: Control /Conventional Physiotherapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density (BMD) of femoral neck and lumbar spine
. Groups will be evaluated using dual energy X-ray absorptiometry DXA (DPX-IQ, version 4.6A).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start20 Feb 2026
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome (DS)Studies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Saeed Alsakhawi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328165
- Sponsor's protocol ID
- P.T.REC/012/005953
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Stability vs Respiratory Muscle Training in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07328165
- Acronym / sponsor ID
- P.T.REC/012/005953
- Conditions
- Down Syndrome (DS), Low Bone Mineral Density
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 9 Jan 2026 (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.
Children with Down syndrome often exhibit diminished physical fitness levels and lower bone mass. Numerous factors contribute to this decrease in bone mass density, including decreased levels of leptin, reduced muscle mass and strength, impaired balance, and skeletal abnormalities. These factors further exacerbate the risk of developing osteoporosis in this population. Therefore, it is crucial to prioritize interventions that focus on maximizing peak bone mass during childhood in order to enhance the quality of life for adults with Down syndrome. The study aims to compare the impact of core stability exercises and respiratory muscle strengthening exercises on bone mineral density in children with Down syndrome. Sixty Children with Down syndrome will be assessed and included in this study. The age of children will range from 10 to 13 years. Children will be allocated randomly into three groups (control and two study group A \& B). The control group receives a physical therapy program, study group A receives traditional physical therapy program with core stability exercises, and study group B receives traditional physical therapy program with respiratory muscle strengthening exercises. Groups will be evaluated using dual energy X-ray absorptiometry DXA (DPX-IQ, version 4.6A). Bone mineral density (BMD) of femoral neck and lumbar spine will be determined and the mean density will be expressed as g/cm2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core Stability Exercise Group | Experimental | Behavioral: Core Stability Exercise GroupThis group will receive core stability exercises in addition to physical therapy program as control group. |
| Respiratory Muscle Strengthening Group | Experimental | Device: Respiratory Muscle Strengthening GroupThis group will receive respiratory muscle strengthening exercises in addition to physical therapy program as control group |
| Control Group | Active comparator | Behavioral: Control /Conventional Physiotherapy GroupThe control group will receive the physical therapy program and conduct three times peer week over 8 consecutive weeks under the supervision of a physical rehabilitation specialist |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age will range from 10-13 years
- Diagnosed with Down syndrome.
- Children with the ability to understand and follow verbal commands and instructions used during training and tests
- Able to stand and walk independently
Key exclusion criteria (3 listed)
- Any neurological, mobility disorders, vision or hearing loss, cardiac anomalies or musculoskeletal disorder
- With asthma or any chronic chest diseases
- With significant tightness or deformities in the lower limbs and limber spine
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 |
|---|---|---|
| Core Stability Exercise GroupBased on Jeffrey's protocol, the protocol includes specific spinal stabilization exercises, lumbar-pelvic proprioception retraining, and abdominal maneuvers (holding the abdomen in) and multifidus muscle contraction, followed by maintaining stabilization maneuver using dynamic stability achieved in different positions (supine, prone, and squatting) and addition of dynamic elements (limb movement, use of Swiss ball) in later stages. | Behavioural | Core Stability Exercise Group |
| Respiratory Muscle Strengthening GroupBy using a threshold inspiratory muscle training (IMT) (Respironics, Cedar Grove, NJ, USA). Frequency 3 time per week for 8 weeks. It is a spring-loaded valve that inspiratory resistance can be adjusted. This training last for 30 min. To develop muscle strength; during the first 10 min of practice, threshold IMT will be used in 10 series of 60s each, separated by rest periods of 60s. To develop endurance; during the final 20 min, the equipment will be used uninterruptedly. Prior to the beginning of each session, the pressure threshold load throughout the practice will be 50 % of Maximum Inspiratory pressure that will be calculated during the evaluation of children. | Device | Respiratory Muscle Strengthening Group |
| Control /Conventional Physiotherapy GroupThe primary focus of the program was to improve bone mineral density. Each session will be conducted 60 minutes and consist of weight bearing exercises and strengthen exercises in the form of isometric exercises; | Behavioural | Control Group |
Primary outcome
Bone mineral density (BMD) of femoral neck and lumbar spine
Time frame: 8 weeks
. Groups will be evaluated using dual energy X-ray absorptiometry DXA (DPX-IQ, version 4.6A).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stability Exercise Group and Respiratory Muscle Strengthening Group in people with Down Syndrome (DS) and Low Bone Mineral Density, 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Bone mineral density (BMD) of femoral neck and lumbar spine (time frame: 8 weeks). 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 11 May 2026.