The Effect of Physical Activity Autonomic Response of Autism Spectrum

NCT ID: NCT05725733

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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).

Conditions

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Neurodevelopmental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Physical Therapy

Intervention Type 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.

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)

Group Type ACTIVE_COMPARATOR

Physical Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Treadmill walking program

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jazan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mohammed Moustafa

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed M Ahmed

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Jazan University

Locations

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Jazan University

Jizan, Gizan, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 38617566 (View on PubMed)

Other Identifiers

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2265749561

Identifier Type: -

Identifier Source: org_study_id

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