NCT06831188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

26 days

First QC Date

February 13, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

autismexerciseMOBAK-16-min walk test

Outcome Measures

Primary Outcomes (5)

  • 6-minute walk test

    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

    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

    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

  • body composition analyses

    Body fat percentage will be measured by using Bioimpedance measurement system

    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

    Through study completion, an average of 12 weeks

Study Arms (2)

specific type exercise group

EXPERIMENTAL

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

Other: specific type exercise group

daily life exercise group

ACTIVE COMPARATOR

\- random games which includes physical activity

Other: daily life exercise group

Interventions

random games which includes physical activity

daily life 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

specific type exercise group

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • children who are unable to adapt exercise programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderMotor Activity

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

May 20, 2025

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Locations