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The Effect of Physical Activity Autonomic Response of Autism Spectrum

Primary Purpose

Neurodevelopmental Disorders

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
University of Jazan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neurodevelopmental Disorders

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jazan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

children with ASD group.

One hundred typically developed children or control group

Arm Description

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).

They 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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 3, 2023
Last Updated
October 11, 2023
Sponsor
University of Jazan
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1. Study Identification

Unique Protocol Identification Number
NCT05725733
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jazan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
children with ASD group.
Arm Type
Experimental
Arm Description
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).
Arm Title
One hundred typically developed children or control group
Arm Type
Active Comparator
Arm Description
They 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)
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
Treadmill walking program
Intervention Description
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.
Primary Outcome Measure Information:
Title
ECG measurements
Description
A wearable device will be used to collet cardiac ECG data.
Time Frame
One minute
Title
Measurements of respiration
Description
Portable Respiratory Monitor will be used to measure the respiratory activity.
Time Frame
5 minutes
Title
Blood pressure measurement
Description
Manual sphygmomanometer will be used to measure the blood pressure.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Ahmed
Organizational Affiliation
Assistant Professor, Jazan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jazan University
City
Jazan
State/Province
Gizan
ZIP/Postal Code
45142
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Physical Activity Autonomic Response of Autism Spectrum

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