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临床试验/NCT06831188
NCT06831188已完成不适用

The Effect Of Exercise On Performance And Quality Of Life In Children With Autism Spectrum Disorder

Istanbul University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
ABC Turkish form - Turkish Form (ABC).

研究概览

简要总结

The goal of this clinical trial is to learn if regular exercise intervention may improve the health status of the participants diagnosed with autism spectrum disorder, ages between 5-13 years old. The main question it aims to answer is:

  • if combined regular exercise program improves motor skills, repetitive movements, aerobic capacity and quality of life of participants?
  • Researchers will compare the exercising and non-exercising participants to see if regular exercise improves the health related parameters.

Participants will do exercise for 12 weeks regularly.

详细描述

Before and after the exercise program;

  • the parents of the participants will fill out the ABC problem behaviour control scale
  • the participants will perform 6 minute walk test, sit-reach flexibility test, grip strength test. Body fat analysis will be performed by using Bioimpedance Analysis Method.
  • participants will also perform MoBAK-1 test which measures motor competencies

Exercise program include; 10 minutesTreadmill Walk, Playdough or ball squeeze, Towel wring,Throwing to target, catching the tennis ball, bouncing a ball inside borders without losing control, dribbling a ball inside borders without losing control, tandem walk, Single leg stance balance on balance pad or pillow, rolling forward, Jumping exercises, Side stepping, etc.

The implementation of exercise programs, the follow-up process, and data recording methods will be documented and applied by the research team.

Data will be analyzed in the SPSS 28 statistical package program. The data distribution will be checked by Kolmogorov Smirnov and the homogeneity of variances by the Levene test. For variables with normal distribution, One-Way ANOVA will be used for multiple comparisons, and an Independent t-test will be used for pairwise comparisons. Wilcoxon test will be used for pairwise comparisons in dependent variables that do not fit a normal distribution, and the Mann- Whitney U test will be used in independent variables. The relationship between continuous variables will be tested using the correlation coefficient, and the relationship between categorical variables will be tested using the chi-square test. Descriptive statistics will be given as mean ± standard deviation. Results will be considered statistically significant for p<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •children with autism spectrum disorder

排除标准

  • •children who are unable to adapt exercise programs

研究组 & 干预措施

daily life exercise group

Active Comparator

- random games which includes physical activity

干预措施: daily life exercise group (Other)

specific type exercise group

Experimental

The participants will be given exercise programs for 12 weeks, and these exercises will be performed regularly.

干预措施: specific type exercise group (Other)

结局指标

主要结局

ABC Turkish form - Turkish Form (ABC).

时间窗: Through study completion, an average of 12 weeks

Abberant Behavior Checklist-Turkish form is a widely used 57-item assessment tool designed to evaluate and screen for autism spectrum disorders and intellectual disabilities in children and adolescents.

6-minute walk test

时间窗: Through study completion, an average of 12 weeks

The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.

sit-reach test reach flexibility test

时间窗: Through study completion, an average of 12 weeks

The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back

grip strength

时间窗: Through study completion, an average of 12 weeks

Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.

body composition analyses

时间窗: Through study completion, an average of 12 weeks

Body fat percentage will be measured by using Bioimpedance measurement system

MOBAK-1 basic motor competencies

时间窗: Through study completion, an average of 12 weeks

The MOBAK 1 test battery is a recent instrument developed to assess motor competence in primary physical education.The MOBAK-1 testing battery has been r developed with the aim of assessing a wide panel of motor skills in relationship with body movement and object-control abilities

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şensu Dinçer

Medical doctor

Istanbul University

研究点 (1)

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