Autism Spectrum DisorderNCT04047615
The Effects of Exercise on Behavior and Fitness in Children With ASD
A study testing Exercise in people with Autism Spectrum Disorder and Behavior, run by South East Technological University at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Behavior
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2019to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of Autism Spectrum Disorder
Who cannot join
- Any medical condition which excludes the child from partaking in exercise
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Institute of Technology, Carlow
Carlow
Craig Coffey, BSc, 0860797874, Craig.Coffey@itcarlow.ie
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Behavior
- Being tested
- Exercise
- Medical subject headings
- Autism Spectrum Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior
Changes in behavior levels of the children will be assessed using the Aberrant Behavior Checklist and
Measured: 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.
Measured: Change from baseline at Week 4 and Week 8
Secondary outcomes (1)
Fitness Level
The modified eurofit test will be used to investigate fitness levels of the children
Measured: Change from baseline at Wkke 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South East Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047615
- Sponsor's protocol ID
- ASD Intervention
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Exercise Intervention Programme on Behaviour and Fitness Levels in Children With ASD.
- ClinicalTrials.gov ID
- NCT04047615
- Acronym / sponsor ID
- ASD Intervention
- Conditions
- Autism Spectrum Disorder, Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South East Technological UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise effects on Behavior | Experimental | Other: ExerciseAn 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. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of Autism Spectrum Disorder
Key exclusion criteria (1 listed)
- Any medical condition which excludes the child from partaking in exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAn 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. | Other | Exercise effects on Behavior |
Primary outcome
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
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.
1 secondary outcome
Fitness Level
Time frame: Change from baseline at Wkke 4 and Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Autism Spectrum Disorder and Behavior, run by South East Technological University at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig Coffey, BSc (+353860797874, craig.coffey@itcarlow.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior (time frame: Change from baseline at Week 4 and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.