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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04047615
Other study ID # ASD Intervention
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date February 2021

Study information

Verified date August 2019
Source Institute of Technology, Carlow
Contact Craig Coffey, BSc
Phone +353860797874
Email craig.coffey@itcarlow.ie
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date February 2021
Est. primary completion date February 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 13 Years
Eligibility Inclusion Criteria:

• Diagnosis of Autism Spectrum Disorder

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Ireland Institute of Technology, Carlow Carlow

Sponsors (1)

Lead Sponsor Collaborator
Institute of Technology, Carlow

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavior 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
Primary 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.
Change from baseline at Week 4 and Week 8
Secondary Fitness Level The modified eurofit test will be used to investigate fitness levels of the children Change from baseline at Wkke 4 and Week 8
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