Clinical trial NCT06831188: Exercise Efficacy on Autism Spectrum Disorder
Official title: The Effect Of Exercise On Performance And Quality Of Life In Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Keywords: autism
exercise
MOBAK-1
6-min walk test
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: children with autism spectrum disorder

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Exclusion Criteria:

* children who are unable to adapt exercise programs

Primary outcomes:
measure: 6-minute walk test
timeFrame: Through study completion, an average of 12 weeks
measure: sit-reach test reach flexibility test
timeFrame: Through study completion, an average of 12 weeks
measure: grip strength
timeFrame: Through study completion, an average of 12 weeks
measure: body composition analyses
timeFrame: Through study completion, an average of 12 weeks
measure: MOBAK-1 basic motor competencies
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
Other outcomes:
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Study officials:
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