- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06284707
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Paula Esteban-García, PhD
- Phone Number: 926051588
- Email: paula.esteban@uclm.es
Study Contact Backup
- Name: Javier Abián-Vicén, PhD
- Phone Number: 926051588
- Email: javier.abian@uclm.es
Study Locations
-
-
-
Toledo, Spain, 45071
- Recruiting
- Universidad de Castilla La Mancha
-
Contact:
- Paula Esteban-García, PhD
- Phone Number: 925 26 88 00
- Email: paula.esteban@uclm.es
-
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rhythmic_PAU_2024
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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