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

August 7, 2019 updated by: Institute of Technology, Carlow

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Carlow, Ireland
        • Institute of Technology, Carlow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Diagnosis of Autism Spectrum Disorder

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise effects on Behavior
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.
Other: Exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavior
Time Frame: Change from baseline at Week 4 and Week 8
Changes in behavior levels of the children will be assessed using the Aberrant Behavior Checklist and
Change from baseline at Week 4 and Week 8
Behavior
Time Frame: Change from baseline at Week 4 and Week 8

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.
Change from baseline at Week 4 and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fitness Level
Time Frame: Change from baseline at Wkke 4 and Week 8
The modified eurofit test will be used to investigate fitness levels of the children
Change from baseline at Wkke 4 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Technology, Carlow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD intervention

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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