The Effect of Physical Activity Autonomic Response of Autism Spectrum

NCT05725733 | Completed

• 1 other identifier: 2265749561
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (3)

• ECG measurements

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

  One minute

• Measurements of respiration

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

  5 minutes

• Blood pressure measurement

  Manual sphygmomanometer will be used to measure the blood pressure.

  5 minutes

Study Arms (2)

children with ASD group.

EXPERIMENTAL

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

One hundred typically developed children or control group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Treadmill walking program

One hundred typically developed children or control group; children with ASD group.

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

Jazan University

Jizan, Gizan, 45142, Saudi Arabia

Location

Related Publications (1)

• Ahmed MM, Alawna M, Youssef ASA, Amin WM, Alajam RA, Morsy WE, Fayed E, Mohamed AA. Immediate effect of physical activity on the autonomic nervous system in individuals with autism spectrum disorders of different age groups: a randomised trial. BMJ Open Sport Exerc Med. 2024 Apr 11;10(2):e001822. doi: 10.1136/bmjsem-2023-001822. eCollection 2024.

  PMID: 38617566 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Mohamed M Ahmed

  Assistant Professor, Jazan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 13, 2023
• Study Start: April 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 1, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)