Effect of Rhythmic Gymnastics Training in Children With Down Syndrome

Physical Conditioning, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284707
• Other study ID #: Rhythmic_PAU_2024
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 5, 2024

Study information

• Verified date: February 2024
• Source: University of Castilla-La Mancha
• Contact: Paula Esteban-García, PhD
• Phone: 926051588
• Email: paula.esteban[@]uclm.es
• Is FDA regulated: No
• 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: Recruiting
• 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

Related Conditions & MeSH terms

• Down Syndrome
• Physical Conditioning, Human

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"