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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06284707
Other study ID # Rhythmic_PAU_2024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date May 5, 2024

Study information

Verified date February 2024
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 5, 2024
Est. primary completion date March 8, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 20 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
swimming training
2 sessions per week of swimming training
rhythmic gymnastics training
2 training sessions of rhythmic gymnastics

Locations

Country Name City State
Spain Universidad de Castilla La Mancha Toledo

Sponsors (1)

Lead Sponsor Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body composition 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) "baseline" and "immediately post intervention"
Primary Tendon thickness Tendon thickness will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI). "baseline" and "immediately post intervention"
Primary Stiffness tendon 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. "baseline" and "immediately post intervention"
Primary Hamstrings flexibility Hamstrings flexibility will be evaluated with Seat and Reach Test (Fabrication Enterprises Inc., USA). "baseline" and "immediately post intervention"
Primary body mass index Body mass index (BMI; kg/m2) will be calcultated from body mass and height "baseline" and "immediately post intervention"
Primary visceral fat area visceral fat area (area; cm2) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea). "baseline" and "immediately post intervention"
Primary metabolism metabolism (MET; kcal) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea). "baseline" and "immediately post intervention"
Primary tendon elastography Tendon elastography will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI). "baseline" and "immediately post intervention"
Primary balance Balance will be evaluated with the Biodex Balance System stability system (Biodex Medical Systems Inc., USA). "baseline and "immediately post intervention"
Primary functional capacity Functional capacity of the lower body wll be evaluated with Sit to Stand Test adapted. "baseline" and "immediately post intervention"
See also
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