The Effect of Physical Activity Autonomic Response of Autism Spectrum

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725733
• Other study ID #: 2265749561
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: University of Jazan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 1, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurodevelopmental Disorders

Intervention

Other:
• Physical 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.

Locations

Country	Name	City	State
Saudi Arabia	Jazan University	Jazan	Gizan

Sponsors (1)

Lead Sponsor	Collaborator
University of Jazan

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG measurements	A wearable device will be used to collet cardiac ECG data.	One minute
Primary	Measurements of respiration	Portable Respiratory Monitor will be used to measure the respiratory activity.	5 minutes
Primary	Blood pressure measurement	Manual sphygmomanometer will be used to measure the blood pressure.	5 minutes