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Completed

NCT Number: NCT06831188

Exercise Efficacy on Autism Spectrum Disorder

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.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Mental Disorders Motor Activity Neurodevelopmental Disorders

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

children with autism spectrum disorder

-

Exclusion criteria

  • children who are unable to adapt exercise programs

Treatment and study plan

daily life exercise group

Other

random games which includes physical activity

specific type exercise group

Other

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

Primary outcomes

  1. 6-minute walk test

    Time frame: 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.

  2. sit-reach test reach flexibility test

    Time frame: 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

  3. grip strength

    Time frame: 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.

  4. body composition analyses

    Time frame: Through study completion, an average of 12 weeks

    Body fat percentage will be measured by using Bioimpedance measurement system

  5. MOBAK-1 basic motor competencies

    Time frame: 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

  6. ABC Turkish form - Turkish Form (ABC).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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