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Completed

NCT Number: NCT05725733

The Effect of Physical Activity Autonomic Response of Autism Spectrum

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.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jazan University

Jizan, Gizan, 45142, Saudi Arabia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Therapy

Other

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

Primary outcomes

  1. ECG measurements

    Time frame: One minute

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

  2. Measurements of respiration

    Time frame: 5 minutes

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

  3. Blood pressure measurement

    Time frame: 5 minutes

    Manual sphygmomanometer will be used to measure the blood pressure.

Sponsors and collaborators

Lead sponsor

University of Jazan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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