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

NCT ID: NCT07328165

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-04-01

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Core Stability Exercise Group

This group will receive core stability exercises in addition to physical therapy program as control group.

Group Type: EXPERIMENTAL

Core Stability Exercise Group

Intervention Type: BEHAVIORAL

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 Group

This group will receive respiratory muscle strengthening exercises in addition to physical therapy program as control group

Group Type: EXPERIMENTAL

Respiratory Muscle Strengthening Group

Intervention Type: DEVICE

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 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

Group Type: ACTIVE_COMPARATOR

Control /Conventional Physiotherapy Group

Intervention Type: BEHAVIORAL

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;

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

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;

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reham Saeed Alsakhawi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P.T.REC/012/005953

Identifier Type: -

Identifier Source: org_study_id