NCT07410897

Brief Summary

This randomized clinical trial studied whether an adapted aquatic exercise program could improve behavior and physical abilities in children with autism spectrum disorder (ASD). Thirty-five boys aged 6 to 12 years with mild ASD participated in the study. Participants were randomly assigned to either an aquatic exercise group or a control group. The aquatic exercise group took part in a structured, individualized swimming and water-based exercise program twice per week for 16 weeks, while the control group continued their regular academic education without additional exercise. The program focused on water safety, breathing control, and basic swimming movements. Outcomes were measured before and after the 16-week period. Autism-related behaviors were evaluated using the Autism Behavior Checklist. Physical abilities were assessed using flexibility (sit-and-reach test) and handgrip strength measurements. The study aimed to determine whether regular participation in adapted aquatic exercise could reduce autism-related behaviors and improve motor skills that are important for daily life activities in children with ASD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 7, 2026

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Handgrip Strength

    Handgrip strength was measured using a calibrated handgrip dynamometer. Participants performed maximal voluntary contractions, and the highest valid value (kilograms) was recorded.

    Baseline and 16 weeks

  • Autism-Related Behaviors

    Autism-related behaviors were assessed using the Autism Behavior Checklist (ABC), a 57-item questionnaire completed by classroom teachers familiar with the participants' daily behavior patterns. Higher total scores indicate greater severity of autism-related behaviors.

    Baseline and 16 weeks

  • Flexibility

    Flexibility will be assessed using the sit-and-reach test with a standardized sit-and-reach box. Participants perform three trials, and the best score (in centimeters) is recorded for analysis. The score represents the maximum forward reach distance. The scale is continuous, with higher values indicating greater flexibility. Typical values range from negative values (unable to reach the toes) to approximately 30-40 cm, depending on performance.

    Baseline and 16 weeks

Study Arms (2)

Adapted Aquatic Exercise Group

EXPERIMENTAL

Participants in this group participated in a 16-week adapted aquatic exercise program in addition to their regular academic instruction. The program was delivered twice per week for 50 minutes per session and focused on water safety, breathing control, limb propulsion, and progressive freestyle swimming skills using individualized, one-to-one instruction.

Behavioral: Adapted Aquatic Exercise Program

Control Group (Academic Instruction Only)

OTHER

Participants in this group continued to receive their regular academic instruction only and did not participate in any structured physical or aquatic exercise programs during the study period.

Other: Academic Instruction

Interventions

A structured adapted aquatic exercise program conducted over 16 weeks, with two 50-minute sessions per week. Sessions were delivered individually by certified adapted swimming instructors and included water familiarization, pool safety, breathing exercises, upper- and lower-limb propulsion, and progressive freestyle swimming skills.

Adapted Aquatic Exercise Group

Standard academic education provided by the school without participation in structured physical activity or aquatic exercise programs during the study period.

Control Group (Academic Instruction Only)

Eligibility Criteria

Age6 Years - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male children aged 6 to 12 years
  • Clinical diagnosis of mild autism spectrum disorder confirmed by a licensed -child psychiatrist according to DSM-5 criteria
  • Medical clearance for participation in aquatic exercise
  • Ability to follow verbal and visual instructions
  • Ability to imitate fine and gross motor movements
  • Independent in toileting
  • Not participating in structured sports or exercise programs other than standard academic instruction
  • Written informed consent provided by a parent or legal guardian

You may not qualify if:

  • Severe autism spectrum disorder
  • Orthopedic, neurological, or medical conditions that contraindicate participation in aquatic exercise
  • Current participation in structured physical training or sports programs outside of school
  • Inability to safely participate in water-based activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University

Aksaray, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the exercise intervention, participants and instructors could not be blinded. However, outcome assessment and data analysis were conducted by researchers who were blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were stratified by speech impairment status and randomly assigned to either an adapted aquatic exercise group or a control group. Both groups were followed concurrently over a 16-week intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

December 1, 2025

Primary Completion

February 5, 2026

Study Completion

February 6, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations