Autism Spectrum Disorder (ASD)NCT06831188
Exercise Efficacy on Autism Spectrum Disorder
A study testing daily life exercise group and specific type exercise group in people with Autism Spectrum Disorder (ASD), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- daily life exercise group and specific type exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -
Who cannot join
- children who are unable to adapt exercise programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- daily life exercise group, specific type exercise group
- Keywords
- autism, exercise, MOBAK-1, 6-min walk test
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily life exercise groupOther
random games which includes physical activity
specific type exercise groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| specific type exercise group | Experimental | The participants will be given exercise programs for 12 weeks, and these exercises will be performed regularly. Receives: Other: specific type exercise group |
| daily life exercise group | Active comparator | - random games which includes physical activity Receives: Other: daily life exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
Measured: Through study completion, an average of 12 weeks
sit-reach test reach flexibility test
The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back
Measured: Through study completion, an average of 12 weeks
grip strength
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.
Measured: Through study completion, an average of 12 weeks
body composition analyses
Body fat percentage will be measured by using Bioimpedance measurement system
Measured: Through study completion, an average of 12 weeks
MOBAK-1 basic motor competencies
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
Measured: Through study completion, an average of 12 weeks
ABC Turkish form - Turkish Form (ABC).
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.
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start20 Mar 2025
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şensu Dinçer, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831188
- Sponsor's protocol ID
- autism spectrum disorder-SY
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Exercise On Performance And Quality Of Life In Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06831188
- Acronym / sponsor ID
- autism spectrum disorder-SY
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- autism, exercise, MOBAK-1, 6-min walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| specific type exercise group | Experimental | Other: specific type exercise groupThe participants will be given exercise programs for 12 weeks, and these exercises will be performed regularly. |
| daily life exercise group | Active comparator | Other: daily life exercise group- random games which includes physical activity |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- children who are unable to adapt exercise programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daily life exercise grouprandom games which includes physical activity | Other | daily life exercise group |
| specific type exercise group10 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 | Other | specific type exercise group |
Primary outcome
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.
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
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.
body composition analyses
Time frame: Through study completion, an average of 12 weeks
Body fat percentage will be measured by using Bioimpedance measurement system
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing daily life exercise group and specific type exercise group in people with Autism Spectrum Disorder (ASD), run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: Through study completion, an average of 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.