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The Effects of Exercise on Behavior and Fitness in Children With ASD

Primary Purpose

Autism Spectrum Disorder, Behavior

Status

Unknown status

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

4 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Diagnosis of Autism Spectrum Disorder

Exclusion Criteria:

• Any medical condition which excludes the child from partaking in exercise

Sites / Locations

Institute of Technology, Carlow

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise effects on Behavior

Arm Description

An exercise intervention programme will be implemented 3 times a week for an 8 week period of time in a school setting. Each exercise class will last 60 minutes. The exercise classes will be fun for the students to participate in and will involve aspects of fundamental movement skills.

Outcomes

Primary Outcome Measures

Behavior

Changes in behavior levels of the children will be assessed using the Aberrant Behavior Checklist and

Behavior

Changes in behavior levels of the children will be assessed using the Gilliam Autism Rating Scale 2nd Edition. Higher the value (total score) the more likely the individual has Autism.

Secondary Outcome Measures

Fitness Level

The modified eurofit test will be used to investigate fitness levels of the children

Full Information

NCT ID

NCT04047615

First Posted

August 5, 2019

Last Updated

August 7, 2019

Sponsor

Institute of Technology, Carlow

1. Study Identification

Unique Protocol Identification Number

NCT04047615

Brief Title

The Effects of Exercise on Behavior and Fitness in Children With ASD

Official Title

The Effects of an Exercise Intervention Programme on Behaviour and Fitness Levels in Children With ASD.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Anticipated)

Primary Completion Date

February 2021 (Anticipated)

Study Completion Date

February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Technology, Carlow

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will examine the effects of a school based exercise intervention programme on the behaviour and fitness levels in children with autism.

Detailed Description

This study will examine the effects of a school based exercise intervention programme on the behaviour and fitness levels in children with autism. Local primary schools who have an Autism Spectrum Disorder (ASD) class will be approached to participate in the project. The age profile of the children will be 4-12 years of age and they will have mild-sever levels of autism. The exercise intervention programme will be delivered 3 times per week in the schools over an 8 week period. Children will be fitness tested to assess the change in fitness levels over the 8 week period. Questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in behaviour levels as a result of the exercise intervention programme.

6. Conditions and Keywords

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

Autism Spectrum Disorder, Behavior

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise effects on Behavior

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

An exercise intervention programme will be delivered in each school for an 8 week period. Exercise classes will take place 3 times a week and will be of 60 minutes duration.

Primary Outcome Measure Information:

Title

Behavior

Description

Changes in behavior levels of the children will be assessed using the Aberrant Behavior Checklist and

Time Frame

Change from baseline at Week 4 and Week 8

Title

Behavior

Description

Changes in behavior levels of the children will be assessed using the Gilliam Autism Rating Scale 2nd Edition. Higher the value (total score) the more likely the individual has Autism.

Time Frame

Change from baseline at Week 4 and Week 8

Secondary Outcome Measure Information:

Title

Fitness Level

Description

The modified eurofit test will be used to investigate fitness levels of the children

Time Frame

Change from baseline at Wkke 4 and Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Diagnosis of Autism Spectrum Disorder Exclusion Criteria: • Any medical condition which excludes the child from partaking in exercise

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Craig Coffey, BSc

Phone

+353860797874

craig.coffey@itcarlow.ie

First Name & Middle Initial & Last Name or Official Title & Degree

Sharon Kinsella, PhD

Phone

+353599175515

sharon.kinsella@itcarlow.ie

Facility Information:

Facility Name

Institute of Technology, Carlow

City

Carlow

Country

Ireland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Craig Coffey, BSc

Phone

0860797874

Craig.Coffey@itcarlow.ie

12. IPD Sharing Statement

Learn more about this trial

The Effects of Exercise on Behavior and Fitness in Children With ASD

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