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

Sponsor

University of Jazan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05725733

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neurodevelopmental Disorders	Other: Physical Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Feb 12, 2023

Anticipated Primary Completion Date :

Jul 12, 2023

Anticipated Study Completion Date :

Aug 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: children with ASD group. 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).	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. Other Names: Treadmill walking program
Active Comparator: One hundred typically developed children or control group 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)	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. Other Names: Treadmill walking program

Arm

Intervention/Treatment

Experimental: children with ASD group.

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).

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.

Other Names:

Treadmill walking program

Active Comparator: One hundred typically developed children or control group

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)

Other: Physical Therapy

Other Names:

Treadmill walking program

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Jazan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Moustafa, Assistant Professor, University of Jazan

ClinicalTrials.gov Identifier:

NCT05725733

Other Study ID Numbers:

2265749561

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Autism Spectrum Disorder

Neurodevelopmental Disorders

Study Results

No Results Posted as of Feb 13, 2023