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临床试验/NCT06284707
NCT06284707已完成不适用

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

University of Castilla-La Mancha2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
functional capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

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.

入排标准

年龄范围
6 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Disabiluty: mild to moderate

排除标准

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

结局指标

主要结局

functional capacity

时间窗: "baseline" and "immediately post intervention"

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

Stiffness tendon

时间窗: "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.

visceral fat area

时间窗: "baseline" and "immediately post intervention"

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

metabolism

时间窗: "baseline" and "immediately post intervention"

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

Hamstrings flexibility

时间窗: "baseline" and "immediately post intervention"

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

body mass index

时间窗: "baseline" and "immediately post intervention"

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

tendon elastography

时间窗: "baseline" and "immediately post intervention"

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

balance

时间窗: "baseline and "immediately post intervention"

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

Body composition

时间窗: "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

时间窗: "baseline" and "immediately post intervention"

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

次要结局

未报告次要终点

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (2)

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