NCT04047615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

August 5, 2019

Last Update Submit

August 7, 2019

Conditions

Autism Spectrum DisorderBehavior

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Fitness Level

    Change from baseline at Wkke 4 and Week 8

Study Arms (1)

Exercise effects on Behavior

EXPERIMENTAL

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

Interventions

ExerciseOTHER

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.

Exercise effects on Behavior

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of Autism Spectrum Disorder

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Technology, Carlow

Carlow, Ireland

Location

MeSH Terms

Conditions

Autism Spectrum DisorderBehavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Craig Coffey, BSc

CONTACT

+353860797874craig.coffey@itcarlow.ie

Sharon Kinsella, PhD

CONTACT

+353599175515sharon.kinsella@itcarlow.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 7, 2019

Study Start

September 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

IE(1)