Physical Conditioning, HumanNCT06284707
Effect of Rhythmic Gymnastics Training in Children With Down Syndrome
A study testing swimming training and rhythmic gymnastics training in people with Physical Conditioning, Human, run by University of Castilla-La Mancha at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Conditioning, Human
- What is being tested?
- swimming training and rhythmic gymnastics training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 5 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Disabiluty: mild to moderate
Who cannot join
- Any contraindication to exercise
- Severe or profound intellectual disability
- Musculoskeletal disorders that prevented completion of the tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Conditioning, Human
- Being tested
- swimming training, rhythmic gymnastics training
- Keywords
- rhythmic gymnastics, disability, gymnastics training, down syndrome, child
- Medical subject headings
- Motor Activity, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swimming trainingOther
2 sessions per week of swimming training
rhythmic gymnastics trainingOther
2 training sessions of rhythmic gymnastics
| Study group | Role | What they receive |
|---|---|---|
| swimming training | Other | Participants complete 2 swimming training sessions per week. Total program time 10 weeks Receives: Other: swimming training |
| swimming training and rhythmic gymnastics training | Experimental | Participants perform 2 swimming training sessions per week and 2 rhythmic gymnastics training sessions.
Total program time 10 weeks Receives: Other: swimming training; Other: rhythmic gymnastics training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: "baseline" and "immediately post intervention"
Tendon thickness
Tendon thickness will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI).
Measured: "baseline" and "immediately post intervention"
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.
Measured: "baseline" and "immediately post intervention"
Hamstrings flexibility
Hamstrings flexibility will be evaluated with Seat and Reach Test (Fabrication Enterprises Inc., USA).
Measured: "baseline" and "immediately post intervention"
body mass index
Body mass index (BMI; kg/m2) will be calcultated from body mass and height
Measured: "baseline" and "immediately post intervention"
visceral fat area
visceral fat area (area; cm2) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea).
Measured: "baseline" and "immediately post intervention"
metabolism
metabolism (MET; kcal) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea).
Measured: "baseline" and "immediately post intervention"
tendon elastography
Tendon elastography will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI).
Measured: "baseline" and "immediately post intervention"
balance
Balance will be evaluated with the Biodex Balance System stability system (Biodex Medical Systems Inc., USA).
Measured: "baseline and "immediately post intervention"
functional capacity
Functional capacity of the lower body wll be evaluated with Sit to Stand Test adapted.
Measured: "baseline" and "immediately post intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024
- Primary completion8 Mar 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Conditioning, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Abián-Vicén, PhD, Study director, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284707
- Sponsor's protocol ID
- Rhythmic_PAU_2024
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Adapted Rhythmic Gymnastics Training Program in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06284707
- Acronym / sponsor ID
- Rhythmic_PAU_2024
- Conditions
- Physical Conditioning, Human
- Keywords
- rhythmic gymnastics, disability, gymnastics training, down syndrome, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| swimming training | Other | Other: swimming trainingParticipants complete 2 swimming training sessions per week. Total program time 10 weeks |
| swimming training and rhythmic gymnastics training | Experimental | Other: swimming training, Other: rhythmic gymnastics trainingParticipants perform 2 swimming training sessions per week and 2 rhythmic gymnastics training sessions. Total program time 10 weeks |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Disabiluty: mild to moderate
Key exclusion criteria (3 listed)
- Any contraindication to exercise
- Severe or profound intellectual disability
- Musculoskeletal disorders that prevented completion of the tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| swimming training2 sessions per week of swimming training | Other | swimming training, swimming training and rhythmic gymnastics training |
| rhythmic gymnastics training2 training sessions of rhythmic gymnastics | Other | swimming training and rhythmic gymnastics training |
Primary outcome
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)
Tendon thickness
Time frame: "baseline" and "immediately post intervention"
Tendon thickness will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI).
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.
Hamstrings flexibility
Time frame: "baseline" and "immediately post intervention"
Hamstrings flexibility will be evaluated with Seat and Reach Test (Fabrication Enterprises Inc., USA).
body mass index
Time frame: "baseline" and "immediately post intervention"
Body mass index (BMI; kg/m2) will be calcultated from body mass and height
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).
metabolism
Time frame: "baseline" and "immediately post intervention"
metabolism (MET; kcal) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea).
tendon elastography
Time frame: "baseline" and "immediately post intervention"
Tendon elastography will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI).
balance
Time frame: "baseline and "immediately post intervention"
Balance will be evaluated with the Biodex Balance System stability system (Biodex Medical Systems Inc., USA).
functional capacity
Time frame: "baseline" and "immediately post intervention"
Functional capacity of the lower body wll be evaluated with Sit to Stand Test adapted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Abián-Vicén, PhD study director
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing swimming training and rhythmic gymnastics training in people with Physical Conditioning, Human, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: "baseline" and "immediately post intervention"). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.