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NCT Number: NCT05191654

Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD

Congenital heart diseases (CHD) are detected in 40-60% of individuals with Down syndrome (DS) and increase the risk of developmental delay in the presence of syndromes. The aim of the study was to compare cardiopulmonary parameters, gross motor development and hand grip strength in DS children with and without CHD. Demographic variables, cardiopulmonary parameters and echocardiographic values were recorded. Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer.

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Key information

Conditions

Congenital Heart Defects Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Gross Motor Development Delay Heart Defects, Congenital Heart Diseases Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Atılım University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Down syndrome as a result of genetic analysis,
  • For the congenital heart disease group; undergoing cardiac surgery at least 6 months before the evaluation, diagnosed as CHD by a pediatric cardiologist based on echocardiographic findings,
  • For the group without congenital heart disease, patients who have not undergone cardiac surgery, are asymptomatic with a septal defect smaller than 4-5 mm, are expected to close, and are hemodynamically normal by a pediatric cardiologist,
  • Children whose families were informed about the study and gave written consent to participate in the study were included in the study.

Exclusion criteria

  • Having another genetic abnormality other than Down syndrome,
  • undergoing surgery other than cardiac surgery,
  • Having an orthopedic or neurological problem,
  • Respiratory support,
  • With atlantoaxial instability,
  • Children with hematological disease were not included in the study.

Treatment and study plan

evaluation of cardiopulmonary parameters, gross motor development and hand grip strength

Diagnostic Test

Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer. Cardiopulmonary parameters values was evaluated with echocardiography.

Primary outcomes

  1. Gross Motor Function Measure-88

    Time frame: october 2020- june 2021

    Gross motor development of the participants was evaluated with the Gross Motor Function Measure-88 questionnaire. The value as a percentage was obtained as a result of the survey. Gross Motor Function Measure-88 consists of 5 sections that include the evaluation of Lying & Rolling, Sitting, Crawling & Kneeling, Standing, Walking, Running & Jumping activities. Each item in the sections consists of a 4-point scale. Scores for each section are summed and divided by 5.The maximum score on the scale is 100. A high score indicates good gross motor development.

    0 = does not initiate

    • = initiates
    • = partially completes
    • = completes

  2. Bulb Dynamometer

    Time frame: october 2020- june 2021

    Hand grip strength was measured with a Baseline Pneumatic Bulb Dynamometer (Fabrication Enterprises INC, Elmsford, NY USA). With a bulb dynamometer, the spherical grip force is measured using a rubber balloon tip. The bulb dynamometer has 3 removable sizes. The values measured on the manometer are recorded in kPa. The measurement is repeated 3 times and the highest value is taken.

  3. Left ventricular ejection fraction (EF)

    Time frame: october 2020- june 2021

    Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is obtained by dividing the difference in left ventricular volume at end-diastolic and end-systolic by the end-diastolic left ventricular volume. Left ventricular ejection fraction (EF) indicate the systolic function of the left ventricle. Ejection fraction value show as a percentage (%). The ejection fraction normal value is between 50 percent and 70 percent.

  4. Interventricular septum wall thickness (IVS)

    Time frame: october 2020- june 2021

    Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is important in the risk classification potential of left ventricular systolic function. Its value is show as millimeters (mm).

  5. Left ventricular end-diastolic diameter (LVDd)

    Time frame: october 2020- june 2021

    Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. It is important in the risk classification potential of left ventricular systolic function. Its value is show as millimeters (mm).

  6. Fractional shortening (FS)

    Time frame: october 2020- june 2021

    Echocardiographic findings performed in the last 6 months were evaluated by a pediatric cardiologist. Fractional shortening evaluates left ventricular systolic function. Fractional shortening value show as a percentage (%). The value of normal fractional shortening in children is between 28-44%.

  7. Wang Respiratory Score

    Time frame: october 2020- june 2021

    The Wang respiratory score assesses respiratory frequency, wheezing, retraction, and general condition. parameters are scored between 0-3 and summed. A higher score indicates that the situation is getting severe.

Sponsors and collaborators

Lead sponsor

Atılım University

Other

Registry information

Official study title

Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in Children With Down Syndrome With and Without Congenital Heart Disease

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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