The Effect of Physical Activity Autonomic Response of Autism Spectrum

Not Applicable

Completed

• Conditions: Neurodevelopmental Disorders

• Registration Number: NCT05725733
• Lead Sponsor: University of Jazan

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).

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-13
• Study Start: 2023-04-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ECG measurements	One minute	A wearable device will be used to collet cardiac ECG data.
Measurements of respiration	5 minutes	Portable Respiratory Monitor will be used to measure the respiratory activity.
Blood pressure measurement	5 minutes	Manual sphygmomanometer will be used to measure the blood pressure.

Trial Locations

Locations (1)

Jazan University; 🇸🇦 Jazan, Gizan, Saudi Arabia