- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06831188
- Original Trial
Exercise Efficacy on Autism Spectrum Disorder
The Effect Of Exercise On Performance And Quality Of Life In Children With 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34093
- Istanbul Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria: children with autism spectrum disorder
-
Exclusion Criteria:
- children who are unable to adapt exercise programs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: specific type exercise group
The participants will be given exercise programs for 12 weeks, and these exercises will be performed regularly.
|
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
|
|
Active Comparator: daily life exercise group
- random games which includes physical activity
|
random games which includes physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of 12 weeks
|
|
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
|
Through study completion, an average of 12 weeks
|
|
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.
|
Through study completion, an average of 12 weeks
|
|
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
|
Through study completion, an average of 12 weeks
|
|
body composition analyses
Time Frame: Through study completion, an average of 12 weeks
|
Body fat percentage will be measured by using Bioimpedance measurement system
|
Through study completion, an average of 12 weeks
|
|
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.
|
Through study completion, an average of 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- autism spectrum disorder-SY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.