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The Effect of Physical Activity Autonomic Response of Autism Spectrum

The Effect of Physical Activity on The Response of Autonomic Nervous System in Individuals With Autism Spectrum Disorders of Different Age Groups

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05725733
Enrollment
200
Registered
2023-02-13
Start date
2023-04-01
Completion date
2023-08-01
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodevelopmental Disorders

Brief summary

This study will investigate the effect of physical activity on autism spectrum disorder (ASD) in individuals with ASD of different age groups through measuring the hemodynamic, heart activity and respiratory system parameters.

Detailed description

One hundred participants will be included in this study. One hundred typically developed children or control group and one hundred children with ASD group. The age range of participants will be 4 - 18 years old. The participants in both control and ASD groups will be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old, 10-13 years old and, 14-18 years old). Also, ASD group will be categorized according to the symptoms severity using the childhood autism rating scale (CARS). Participants will be excluded if they have any intellectual disability (IQ ≤ 70), co-morbid medical or psychiatric disorders, pervasive developmental disorders (PDD) or Attention-deficit hyperactivity disorders (ADHD). They will also be excluded if they are taking any medications which to affect cardiovascular system, respiratory system, or arousal and balance or any other contraindications to exercises. Wechsler Intelligence Scale for Children-Fourth Edition24 will be used to assess the Intelligence Quotient (IQ).

Interventions

OTHERPhysical Therapy

The participant will walk for 3-minutes at this speed as a warming up period. After these 3-minutes, the speed will be increased gradually up to 5-6 km/minute under the supervision of parents and therapist. The children will perform 10-minute running at this speed. After this, the cooling down exercise will be performed for 3-minutes. The speed will be decreased for 2 km/ minute and gradually stop.

Sponsors

University of Jazan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

A single- blinded randomized controlled study design will be used, the exercise program will be administrated for four weeks, three times per week, and sixteen minutes per session. Heart rate, ECG, Measurements of respiration, and blood pressure will be measured three times every session: at rest before starting exercises (baseline), directly after finishing exercises, and 15 minutes after finishing exercises.

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

1. Children with ASD group with the age range of participants will be 4 - 18 years old 2. Typically developed children with the age range of participants will be 4 - 18 years old

Exclusion criteria

Participants will be excluded if they have the following: * any intellectual disability (IQ ≤ 70) * co-morbid medical or psychiatric disorders. * pervasive developmental disorders (PDD) or Attention-deficit hyperactivity disorders (ADHD). * They will also be excluded if they are taking any medications which to affect cardiovascular system, respiratory system, or arousal and balance or any other contraindications to exercises.

Design outcomes

Primary

MeasureTime frameDescription
ECG measurementsOne minuteA wearable device will be used to collet cardiac ECG data.
Measurements of respiration5 minutesPortable Respiratory Monitor will be used to measure the respiratory activity.
Blood pressure measurement5 minutesManual sphygmomanometer will be used to measure the blood pressure.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026