Exercise Efficacy on Autism Spectrum Disorder

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder (ASD)

• Registration Number: NCT06831188
• Lead Sponsor: Istanbul University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Study Start: 2025-05-20
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

children with autism spectrum disorder

Exclusion Criteria

• children who are unable to adapt exercise programs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6-minute walk test	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	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	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	Through study completion, an average of 12 weeks	Body fat percentage will be measured by using Bioimpedance measurement system
MOBAK-1 basic motor competencies	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