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The Effects of Exercise in Anxiety in Children With ASD

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ClinicalTrials.gov Identifier: NCT03860389
Recruitment Status : Unknown
Verified February 2019 by Institute of Technology, Carlow.
Recruitment status was:  Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
University of Reading
Information provided by (Responsible Party):
Institute of Technology, Carlow

Study Description
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Brief Summary:
This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Anxiety Behavior Other: Exercise Not Applicable

Detailed Description:

This study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism. Local special autism schools and primary and secondary schools with specialised classes for children with autism will be approached to participate in the project. The age profile of the children will be 4-18 yrs of age and they will have mild-severe levels of autism. The exercise programme will delivered 3 times per week in the schools over periods of 8-16 weeks dependent on the severity of autism within the children.

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 anxiety levels and behaviour as a result of the exercise programme.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of a School Based Exercise Programme on Behaviour and Anxiety in Children With ASD
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : June 24, 2019
Estimated Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise effects on anxiety
An exercise programme will be administered 3 times a week for up to an 16 week period of time in a school setting. Each exercise class will last 60 minutes. The exercise classes will involve aspects of fundamental movement skills and will be fun for the students to participate in.
 Other: Exercise
An exercise programme will be delivered in the school for a period of up to 16 weeks. Exercise classes will take place 3 times a week and will be of 60 minutes duration.


Outcome Measures
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Primary Outcome Measures :
  1. Anxiety [ Time Frame: Change from baseline at Week 8 and Week 16 ]
    Changes in anxiety levels of the children will be assessed using the Anxiety Scale for Children -ASD.

  2. Behaviour [ Time Frame: Change from baseline at Week 8 and Week 16 ]
    Changes in the behaviour of the children will be assessed using the Nisingor Child Behaviour Rating Form


Secondary Outcome Measures :
  1. Fitness level [ Time Frame: Change from baseline at Week 8 and Week 16 ]
    The modified Eurofit test will be used to assess the fitness levels of children


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of autism spectrum disorder

Exclusion Criteria:

  • Any medical condition which excludes the child from partaking in exercise
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860389


Contacts
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Contact: Sharon Kinsella, PhD. +353599175515 sharon.kinsella@itcarlow.ie
Contact: Marie Carey, BSc. mariec1995@gmail.com

Locations
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Ireland
Sharon Kinsella Recruiting
Carlow, Co. Carlow, Ireland
Contact: Sharon Kinsella, PhD.    +353 599175515    sharon.kinsella@itcarlow.ie   
Sub-Investigator: Marie Carey, BSc         
Sponsors and Collaborators
Institute of Technology, Carlow
University of Reading
Investigators
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Principal Investigator: Sharon Kinsella, PhD IT Carlow
More Information
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Responsible Party: Institute of Technology, Carlow
ClinicalTrials.gov Identifier: NCT03860389    
Other Study ID Numbers: ASD1
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Technology, Carlow:
Autism
Anxiety
Exercise
Behaviour
Additional relevant MeSH terms:
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Anxiety Disorders
Autism Spectrum Disorder
Mental Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders