Clinical trial NCT05725733: The Effect of Physical Activity Autonomic Response of Autism Spectrum
Official title: The Effect of Physical Activity on The Response of Autonomic Nervous System in Individuals With Autism Spectrum Disorders of Different Age Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2023-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: ECG measurements
timeFrame: One minute
measure: Measurements of respiration
timeFrame: 5 minutes
measure: Blood pressure measurement
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Jazan University
state: Gizan
Study officials:
affiliation: Assistant Professor, Jazan University
name: Mohamed M Ahmed
role: PRINCIPAL_INVESTIGATOR
References: