Exercise Efficacy on Autism Spectrum Disorder

NCT ID: NCT06831188

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2025-06-15

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.

Conditions

Autism Spectrum Disorder (ASD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

specific type exercise group

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

Group Type: EXPERIMENTAL

specific type exercise group

Intervention Type: 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

daily life exercise group

\- random games which includes physical activity

Group Type: ACTIVE_COMPARATOR

daily life exercise group

Intervention Type: OTHER

random games which includes physical activity

Interventions

daily life exercise group

random games which includes physical activity

Intervention Type: OTHER

specific type exercise group

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

• children who are unable to adapt exercise programs

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Şensu Dinçer

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

autism spectrum disorder-SY

Identifier Type: -

Identifier Source: org_study_id