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Completed

NCT Number: NCT06284707

Effect of Rhythmic Gymnastics Training in Children With Down Syndrome

Some of the clinical characteristics of people with Down syndrome (DS) are orthopedic, cardiovascular, neuromuscular, visual, cognitive and perceptual disorders, which directly affect the quality of their movements. Children with DS often have a sedentary lifestyle or low levels of physical activity which exacerbates problems related to obesity and overall physical health. Therefore, the practice of physical exercise in this type of population is essential to improve their health-related physical fitness. The aim of this study was to analyze the influence of an adapted rhythmic gymnastics training program on body composition, tendon architecture and stiffness, and physical capacity in children with DS.

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Key information

Conditions

Physical Conditioning, Human Abnormalities, Multiple Behavior Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Castilla La Mancha

Toledo, 45071, Spain

About this study

Children with DS with medium to moderate intellectual disabilities are required to participate. Participants will complete 10 weeks of training, two days per week. They will be divided into two groups: the Control Group will receive two swimming sessions per week and the Experimental Group will receive two swimming sessions plus two rhythmic gymnastics sessions. Before and after the application of the program, the following will be evaluated: body composition by Inbody 720, muscular architecture and elastography by Logiq® S8 ultrasound scanner and tendon stiffness by Myoton® Pro portable myotonometer. The tendons to be studied will be the Achilles tendon and the patellar tendon.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Disabiluty: mild to moderate

Exclusion criteria

  • Any contraindication to exercise
  • Severe or profound intellectual disability
  • Musculoskeletal disorders that prevented completion of the tests

Treatment and study plan

swimming training

Other

2 sessions per week of swimming training

rhythmic gymnastics training

Other

2 training sessions of rhythmic gymnastics

Primary outcomes

  1. Body composition

    Time frame: "baseline" and "immediately post intervention"

    Body compisition will be assessed with the Inbody 720 (Bioespace, Seoul, Korea). In this test body mass (BM; kg), muscle mass (MM; kg), fat mass (FM; kg), lean mass (LM; kg), fat-free mass (FF; kg)

  2. Tendon thickness

    Time frame: "baseline" and "immediately post intervention"

    Tendon thickness will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI).

  3. Stiffness tendon

    Time frame: "baseline" and "immediately post intervention"

    Stiffness tendon will be evaluated with Myoton® Pro hand-held myotonometer (Myoton AS, Tallinn, Estonia). In this test, the mechanical properties of the Achilles tendon will be measured.

  4. Hamstrings flexibility

    Time frame: "baseline" and "immediately post intervention"

    Hamstrings flexibility will be evaluated with Seat and Reach Test (Fabrication Enterprises Inc., USA).

  5. body mass index

    Time frame: "baseline" and "immediately post intervention"

    Body mass index (BMI; kg/m2) will be calcultated from body mass and height

  6. visceral fat area

    Time frame: "baseline" and "immediately post intervention"

    visceral fat area (area; cm2) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea).

  7. metabolism

    Time frame: "baseline" and "immediately post intervention"

    metabolism (MET; kcal) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea).

  8. tendon elastography

    Time frame: "baseline" and "immediately post intervention"

    Tendon elastography will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI).

  9. balance

    Time frame: "baseline and "immediately post intervention"

    Balance will be evaluated with the Biodex Balance System stability system (Biodex Medical Systems Inc., USA).

  10. functional capacity

    Time frame: "baseline" and "immediately post intervention"

    Functional capacity of the lower body wll be evaluated with Sit to Stand Test adapted.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Registry information

Official study title

Effect of an Adapted Rhythmic Gymnastics Training Program in Children With Down Syndrome

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 29, 2024
Registry last updated
May 16, 2024

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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