AutismNCT04199507
Physical Fitness in Autism
An observational study of Autism, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Although there are some studies investigating the physical activity levels of children with autism in the literature, no comprehensive study investigating the relationship between posture and physical fitness parameters, family anxiety level and quality of life of individuals with autism who have continued physical… Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- physical fitness assessment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2019to 16 Apr 2020
- Phase
- Observational
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Autism is a spectrum disorder, each person with autism has a distinct set of strengths and challenges. The ways in which people with autism learn, think and problem-solve can range from highly skilled to severely challenged. Some people with ASD may require significant support in their daily lives, while others may need less support and, in some cases, live entirely independently.
Who may be able to join
- Being diagnosed with mild to moderate autism,
- To have the ability to emulate,
- To have a cognitive level and cooperation capacity that will not hinder the implementation of assessment scales,
Who cannot join
- Having any systemic chronic disease and neurological disorder
- During the last 6 months, individuals wih autism in the process will affect physical fitness for fracture, surgery and so on.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postural Disorders and Physical Fitness Parameters, Family Anxiety Level and Quality of Life Between Individuals With Autism and Healthy Individuals Who Continue Physical Activity Program
Although there are some studies investigating the physical activity levels of children with autism in the literature, no comprehensive study investigating the relationship between posture and physical fitness parameters, family anxiety level and quality of life of individuals with autism who have continued physical activity program has not been found. The aim of our study is to compare postural disorders and physical fitness parameters, family anxiety level and quality of life between individuals with autism and healthy individuals attending physical activity program.
- Conditions
- Autism
- Being tested
- physical fitness assessment
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical fitness assessmentOther
assessment
| Study group | Role | What they receive |
|---|---|---|
| Autism | Assessment of physical activity level and physical fitness Receives: Other: physical fitness assessment | |
| Healthy | Assessment of physical activity level and physical fitness Receives: Other: physical fitness assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical fitness
Münich fitness test
Measured: 1 month
Secondary outcomes (3)
Posture analysis
New york posture analysis
Measured: 1 month
Physical activity level
Godin leisure time activity questionnaire
Measured: 1 month
Family Anxiety Level
State-Trait Anxiety Inventory: Scores range from 20 to 80. Scores are positively correlated with higher levels of anxiety
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start16 Dec 2019
- Primary completion16 Apr 2020
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Kübra Şahan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199507
- Sponsor's protocol ID
- GO18/905
- Status last verified
- Aug 2020
- First submitted
- 12 Dec 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postural Disorders and Physical Fitness Parameters, Family Anxiety Level and Quality of Life Between Individuals With Autism and Healthy Individuals Who Continue Physical Activity Program
- ClinicalTrials.gov ID
- NCT04199507
- Acronym / sponsor ID
- GO18/905
- Conditions
- Autism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 16 Dec 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.
Although there are some studies investigating the physical activity levels of children with autism in the literature, no comprehensive study investigating the relationship between posture and physical fitness parameters, family anxiety level and quality of life of individuals with autism who have continued physical activity program has not been found. The aim of our study is to compare postural disorders and physical fitness parameters, family anxiety level and quality of life between individuals with autism and healthy individuals attending physical activity program.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism | – | Other: physical fitness assessmentAssessment of physical activity level and physical fitness |
| Healthy | – | Other: physical fitness assessmentAssessment of physical activity level and physical fitness |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Autism is a spectrum disorder, each person with autism has a distinct set of strengths and challenges. The ways in which people with autism learn, think and problem-solve can range from highly skilled to severely challenged. Some people with ASD may require significant support in their daily lives, while others may need less support and, in some cases, live entirely independently.
Key inclusion criteria (3 listed)
- Being diagnosed with mild to moderate autism,
- To have the ability to emulate,
- To have a cognitive level and cooperation capacity that will not hinder the implementation of assessment scales,
Key exclusion criteria (2 listed)
- Having any systemic chronic disease and neurological disorder
- During the last 6 months, individuals wih autism in the process will affect physical fitness for fracture, surgery and so on.
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 |
|---|---|---|
| physical fitness assessmentassessment | Other | Autism, Healthy |
Primary outcome
Physical fitness
Time frame: 1 month
Münich fitness test
3 secondary outcomes
Posture analysis
Time frame: 1 month
Physical activity level
Time frame: 1 month
Family Anxiety Level
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 11 Aug 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical fitness (time frame: 1 month). 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 11 Aug 2020.