NCT06284707

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2024

Completed
Last Updated

May 16, 2024

Status Verified

February 1, 2024

Enrollment Period

7 days

First QC Date

February 2, 2024

Last Update Submit

May 15, 2024

Conditions

Keywords

rhythmic gymnasticsdisabilitygymnastics trainingdown syndromechild

Outcome Measures

Primary Outcomes (10)

  • 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"

  • Tendon thickness

    Tendon thickness will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI).

    "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.

    "baseline" and "immediately post intervention"

  • Hamstrings flexibility

    Hamstrings flexibility will be evaluated with Seat and Reach Test (Fabrication Enterprises Inc., USA).

    "baseline" and "immediately post intervention"

  • body mass index

    Body mass index (BMI; kg/m2) will be calcultated from body mass and height

    "baseline" and "immediately post intervention"

  • visceral fat area

    visceral fat area (area; cm2) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea).

    "baseline" and "immediately post intervention"

  • metabolism

    metabolism (MET; kcal) will be assessed with the Inbody 720 (Bioespace, Seoul, Korea).

    "baseline" and "immediately post intervention"

  • tendon elastography

    Tendon elastography will be evaluated with the Logiq® S8 ultrasound machine (GE Healthcare, Milwaukee, WI).

    "baseline" and "immediately post intervention"

  • balance

    Balance will be evaluated with the Biodex Balance System stability system (Biodex Medical Systems Inc., USA).

    "baseline and "immediately post intervention"

  • functional capacity

    Functional capacity of the lower body wll be evaluated with Sit to Stand Test adapted.

    "baseline" and "immediately post intervention"

Study Arms (2)

swimming training

OTHER

Participants complete 2 swimming training sessions per week. Total program time 10 weeks

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

Other: swimming trainingOther: rhythmic gymnastics training

Interventions

2 sessions per week of swimming training

swimming trainingswimming training and rhythmic gymnastics training

2 training sessions of rhythmic gymnastics

swimming training and rhythmic gymnastics training

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Disabiluty: mild to moderate

You may not qualify if:

  • Any contraindication to exercise
  • Severe or profound intellectual disability
  • Musculoskeletal disorders that prevented completion of the tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Castilla La Mancha

Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Motor ActivityDown Syndrome

Condition Hierarchy (Ancestors)

BehaviorIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Javier Abián-Vicén, PhD

    University of Castilla-La Mancha

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The care provider will be responsible for administering the training program. Two different people will develop swimming training and rhythmic gymnastics training. Each participant will be assigned a code. The researcher will process the data with the code of each participant.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 29, 2024

Study Start

March 1, 2024

Primary Completion

March 8, 2024

Study Completion

May 5, 2024

Last Updated

May 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations