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Clinical Trials/NCT05725733
NCT05725733
Completed
Not Applicable

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

University of Jazan1 site in 1 country200 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurodevelopmental Disorders
Sponsor
University of Jazan
Enrollment
200
Locations
1
Primary Endpoint
ECG measurements
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Jazan
Responsible Party
Principal Investigator
Principal Investigator

Mohammed Moustafa

Assistant Professor

University of Jazan

Eligibility Criteria

Inclusion Criteria

  • Children with ASD group with the age range of participants will be 4 - 18 years old
  • 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.

Outcomes

Primary Outcomes

ECG measurements

Time Frame: One minute

A wearable device will be used to collet cardiac ECG data.

Measurements of respiration

Time Frame: 5 minutes

Portable Respiratory Monitor will be used to measure the respiratory activity.

Blood pressure measurement

Time Frame: 5 minutes

Manual sphygmomanometer will be used to measure the blood pressure.

Study Sites (1)

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