Effect of Rhythmic Gymnastics Training in Children With Down Syndrome

March 7, 2024 updated by: University of Castilla-La Mancha

Effect of an Adapted Rhythmic Gymnastics Training Program 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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Toledo, Spain, 45071
        • Recruiting
        • Universidad de Castilla La Mancha
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: swimming training
Participants complete 2 swimming training sessions per week. Total program time 10 weeks
2 sessions per week of swimming training
Experimental: swimming training and rhythmic gymnastics training

Participants perform 2 swimming training sessions per week and 2 rhythmic gymnastics training sessions.

Total program time 10 weeks

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Javier Abián-Vicén, PhD, University of Castilla-La Mancha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 8, 2024

Study Completion (Estimated)

May 5, 2024

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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