The Impact of Core Stability Versus Respiratory Muscle Strengthening Exercises on Bone Mineral Density in Children With Down Syndrome

May 6, 2026 updated by: Reham Saeed Alsakhawi, Cairo University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Reham Alsakahwi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Core Stability Exercise Group
This group will receive core stability exercises in addition to physical therapy program as control group.
Behavioral: Core Stability Exercise Group
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.
Experimental: Respiratory Muscle Strengthening Group
This group will receive respiratory muscle strengthening exercises in addition to physical therapy program as control group
Device: Respiratory Muscle Strengthening Group
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.
Active Comparator: Control Group
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
Behavioral: Control /Conventional Physiotherapy Group
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;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/005953

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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