Autism Spectrum DisorderPAASDNCT04950517
Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
The purpose of this study is to increase knowledge and insights with regard to physical activity behavior in adolescents with Autism Spectrum Disorder. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 76 participants
- Where
- 2 sitesBelgium
- Study dates
- 18 Nov 2021to 25 Oct 2023
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants (wave 1 + wave 2 participants) will be recruited from the Autism Expertise Center (UPC Z.org KU Leuven), by contacting (special education) schools and the autism societies. Summary flyers will be distributed via schools, autism societies and social media.
Who may be able to join
- Written informed consent/assent
- ASD diagnosis according to the DSM-IV/5
- Proficient knowledge of Dutch
Who cannot join
- A physical disability hampering the administration of the standardized tests (e.g. unable to sit on a bicycle/perform a motor skill test in standing position)
- Participants with an intellectual disability (defined as an intelligence quotient < 70)
- Participants with severe medical problems (e.g. severe metabolic disorders, oncological disease, diabetes), because of safety reasons
- Wave 1 participants only: the use of antipsychotics, because of safety reasons in the context of performing a maximal exercise test
- Participation in another clinical trial
- In case of pregnancy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder: Reliability, Validity and Correlates
The purpose of this study is to increase knowledge and insights with regard to physical activity behavior in adolescents with Autism Spectrum Disorder.
Read the detailed description
Low levels of physical activity (PA) in adolescents with Autism Spectrum Disorder (ASD) increase the risk for both physical and mental health problems during adolescence and subsequent adulthood. To enable the identification of adolescents with ASD at risk for developing an inactive lifestyle and to inform the future design of high-quality, evidence-based and ASD-specific PA interventions and programs, several gaps of the current literature need to be addressed.
- To date, no PA and cardiorespiratory fitness (CRF) tests have been validated in adolescents with ASD, causing an inability to accurately assess and interpret these two important health markers.
- There is a lack of knowledge regarding PA correlates in this population, resulting in difficulties to identify adolescents with ASD at risk of developing an inactive lifestyle.
- It is still unknown why adolescents with ASD are predominantly inactive and qualitative research of the perspectives of adolescents with ASD towards PA participation in order to understand their PA behavior is scant.
Therefore, the aims of this project with regard to adolescents with ASD are:
- To examine the concurrent validity of two self-report PA instruments and the concurrent validity and test-retest reliability of a submaximal CRF test.
- To determine potential complex and multiple (interactions between) correlates of PA, using a comprehensive assessment protocol.
- To explore the perspectives of adolescents with ASD concerning the barriers and facilitators of PA participation.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Physical activity, Adolescents, Cardiorespiratory fitness
- Medical subject headings
- Autism Spectrum Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wave 1 participants | The study consists of three work packages. Wave 1 participants will be included in all work packages. | |
| Wave 2 participants | The study consists of three work packages. Wave 2 participants will only be recruited for work package 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent validity of the Physical Activity Vital Sign (questionnaire) and an Online Physical Activity Logbook (m-Path app) by using accelerometry (Actigraph model wGT3X-BT) as the criterion measure in adolescents with Autism Spectrum Disorder
The Physical Activity Vital Sign (PAVS) is a questionnaire consisting of 2 questions to measure the amount of moderate-to-vigorous physical activity (MVPA) participation during a typical week (total minutes MVPA/week). The Online Physical Activity Logbook (OPAL) is designed to obtain information regarding physical activity type and its intensity in blocks of 30 minutes (average minutes/week and average minutes/day spent in light, moderate, moderate-to-vigorous and vigorous physical activity. Accelerometry (ActiGraph model wGT3X-BT) will be used as the criterion measure. Accelerometer data will be downloaded, screened and processed using ActiGraph Actilife 6 software to determine the average daily and weekly minutes spent in light, moderate, moderate-to-vigorous and vigorous physical activity.
Measured: Wave 1 participants will wear the accelerometers for seven consecutive days. After, they will be asked to fill out the PAVS. Next, wave 1 participants will wear the accelerometers again for 7 consecutive days and will fill out the OPAL.
Concurrent validity of a submaximal cardiorespiratory fitness test in adolescents with Autism Spectrum Disorder
Examination of the concurrent validity of the Astrand-Rhyming Test (ART). The ART is a submaximal cardiorespiratory fitness test on a bicycle to estimate VO2 max. A maximal cardiorespiratory fitness test (cardiopulmonary exercise test (CPET)) will be used as the criterion measure. The CPET is also a cardiorespiratory fitness test on a bicycle and measures VO2 max.
Measured: Wave 1 participants will perform the ART (total duration approx 20 minutes) and the CPET (total duration approx 20 minutes). The time between both cardiorespiratory fitness tests will be approx 9 days.
The test-retest reliability of a submaximal cardiorespiratory fitness test in adolescents with Autism Spectrum Disorder
Examination of the test-retest reliability of the Astrand-Rhyming Test (ART). The ART is a submaximal cardiorespiratory fitness test on a bicycle to estimate VO2 max. Participants will perform the ART twice in order to examine the test-retest reliability of this submaximal exercise test.
Measured: Participants will perform the ART twice. The time between both test moments will be approx 19 days and the total duration of each test will be approx 20 minutes.
Determination of (interactions between) intrapersonal correlates of physical activity in adolescents with Autism Spectrum Disorder by using a comprehensive assessment protocol with standardized assessment tools
(Interactions between) intrapersonal correlates of physical activity will be determined by using a comprehensive assessment protocol with standardized assessment tools (online questionnaires for the participants and their parents, clinical assessment tools). The potential intrapersonal correlates of physical activity that will be assessed are: demographic factors (socioeconomic status, age, gender, number of siblings and household type); psychological/cognitive/emotional factors (maladaptive functioning, autism severity level, sensory problems, developmental problems); physical profile factors (cardiometabolic risk, overweight/obesity, medical comorbidity, motor skills, body adiposity) and behavioral factors (screen time, time of the day and week being physically active). Physical activity levels (total minutes of moderate-to-vigorous physical activity) will be obtained by using accelerometers (ActiGraph model wGT3X-BT).
Measured: Participants (wave 1+2) will wear the accelerometers for seven consecutive days. Clinical assessments and online questionnaires for adolescents will be executed at one visit. Parents will fill out the online questionnaires at home (60 minutes).
Exploration of the barriers and facilitators adolescents with Autism Spectrum Disorder experience with regard to physical activity participation
Semi-structured interviews will be used to explore the barriers and facilitators adolescents with Autism Spectrum Disorder experience with regard to physical activity participation.
The interview manual is designed with questions targeting all levels of the socio-ecological model.
Measured: One-on-one in-depth interviews for wave 1 participants will take place according to the adolescent's preference: online (chat) interview or face to face interview. An average duration of 45 minutes for each interview will be expected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start18 Nov 2021
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tine Van Damme, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950517
- Sponsor's protocol ID
- S65474
- Acronym
- PAASD
- Status last verified
- May 2024
- First submitted
- 14 Jun 2021
- Last updated
- 26 Jun 2024
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder: Reliability, Validity and Correlates
- ClinicalTrials.gov ID
- NCT04950517
- Acronym / sponsor ID
- PAASD / S65474
- Conditions
- Autism Spectrum Disorder
- Keywords
- Physical activity, Adolescents, Cardiorespiratory fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 6 Jul 2021 (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.
The purpose of this study is to increase knowledge and insights with regard to physical activity behavior in adolescents with Autism Spectrum Disorder.
Detailed description
Low levels of physical activity (PA) in adolescents with Autism Spectrum Disorder (ASD) increase the risk for both physical and mental health problems during adolescence and subsequent adulthood. To enable the identification of adolescents with ASD at risk for developing an inactive lifestyle and to inform the future design of high-quality, evidence-based and ASD-specific PA interventions and programs, several gaps of the current literature need to be addressed.
- To date, no PA and cardiorespiratory fitness (CRF) tests have been validated in adolescents with ASD, causing an inability to accurately assess and interpret these two important health markers.
- There is a lack of knowledge regarding PA correlates in this population, resulting in difficulties to identify adolescents with ASD at risk of developing an inactive lifestyle.
- It is still unknown why adolescents with ASD are predominantly inactive and qualitative research of the perspectives of adolescents with ASD towards PA participation in order to understand their PA behavior is scant.
Therefore, the aims of this project with regard to adolescents with ASD are:
- To examine the concurrent validity of two self-report PA instruments and the concurrent validity and test-retest reliability of a submaximal CRF test.
- To determine potential complex and multiple (interactions between) correlates of PA, using a comprehensive assessment protocol.
- To explore the perspectives of adolescents with ASD concerning the barriers and facilitators of PA participation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wave 1 participants | – | –The study consists of three work packages. Wave 1 participants will be included in all work packages. |
| Wave 2 participants | – | –The study consists of three work packages. Wave 2 participants will only be recruited for work package 2. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants (wave 1 + wave 2 participants) will be recruited from the Autism Expertise Center (UPC Z.org KU Leuven), by contacting (special education) schools and the autism societies. Summary flyers will be distributed via schools, autism societies and social media.
Key inclusion criteria (3 listed)
- Written informed consent/assent
- ASD diagnosis according to the DSM-IV/5
- Proficient knowledge of Dutch
Key exclusion criteria (6 listed)
- A physical disability hampering the administration of the standardized tests (e.g. unable to sit on a bicycle/perform a motor skill test in standing position)
- Participants with an intellectual disability (defined as an intelligence quotient < 70)
- Participants with severe medical problems (e.g. severe metabolic disorders, oncological disease, diabetes), because of safety reasons
- Wave 1 participants only: the use of antipsychotics, because of safety reasons in the context of performing a maximal exercise test
- Participation in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concurrent validity of the Physical Activity Vital Sign (questionnaire) and an Online Physical Activity Logbook (m-Path app) by using accelerometry (Actigraph model wGT3X-BT) as the criterion measure in adolescents with Autism Spectrum Disorder
Time frame: Wave 1 participants will wear the accelerometers for seven consecutive days. After, they will be asked to fill out the PAVS. Next, wave 1 participants will wear the accelerometers again for 7 consecutive days and will fill out the OPAL.
The Physical Activity Vital Sign (PAVS) is a questionnaire consisting of 2 questions to measure the amount of moderate-to-vigorous physical activity (MVPA) participation during a typical week (total minutes MVPA/week). The Online Physical Activity Logbook (OPAL) is designed to obtain information regarding physical activity type and its intensity in blocks of 30 minutes (average minutes/week and average minutes/day spent in light, moderate, moderate-to-vigorous and vigorous physical activity. Accelerometry (ActiGraph model wGT3X-BT) will be used as the criterion measure. Accelerometer data will be downloaded, screened and processed using ActiGraph Actilife 6 software to determine the average daily and weekly minutes spent in light, moderate, moderate-to-vigorous and vigorous physical activity.
Concurrent validity of a submaximal cardiorespiratory fitness test in adolescents with Autism Spectrum Disorder
Time frame: Wave 1 participants will perform the ART (total duration approx 20 minutes) and the CPET (total duration approx 20 minutes). The time between both cardiorespiratory fitness tests will be approx 9 days.
Examination of the concurrent validity of the Astrand-Rhyming Test (ART). The ART is a submaximal cardiorespiratory fitness test on a bicycle to estimate VO2 max. A maximal cardiorespiratory fitness test (cardiopulmonary exercise test (CPET)) will be used as the criterion measure. The CPET is also a cardiorespiratory fitness test on a bicycle and measures VO2 max.
The test-retest reliability of a submaximal cardiorespiratory fitness test in adolescents with Autism Spectrum Disorder
Time frame: Participants will perform the ART twice. The time between both test moments will be approx 19 days and the total duration of each test will be approx 20 minutes.
Examination of the test-retest reliability of the Astrand-Rhyming Test (ART). The ART is a submaximal cardiorespiratory fitness test on a bicycle to estimate VO2 max. Participants will perform the ART twice in order to examine the test-retest reliability of this submaximal exercise test.
Determination of (interactions between) intrapersonal correlates of physical activity in adolescents with Autism Spectrum Disorder by using a comprehensive assessment protocol with standardized assessment tools
Time frame: Participants (wave 1+2) will wear the accelerometers for seven consecutive days. Clinical assessments and online questionnaires for adolescents will be executed at one visit. Parents will fill out the online questionnaires at home (60 minutes).
(Interactions between) intrapersonal correlates of physical activity will be determined by using a comprehensive assessment protocol with standardized assessment tools (online questionnaires for the participants and their parents, clinical assessment tools). The potential intrapersonal correlates of physical activity that will be assessed are: demographic factors (socioeconomic status, age, gender, number of siblings and household type); psychological/cognitive/emotional factors (maladaptive functioning, autism severity level, sensory problems, developmental problems); physical profile factors (cardiometabolic risk, overweight/obesity, medical comorbidity, motor skills, body adiposity) and behavioral factors (screen time, time of the day and week being physically active). Physical activity levels (total minutes of moderate-to-vigorous physical activity) will be obtained by using accelerometers (ActiGraph model wGT3X-BT).
Exploration of the barriers and facilitators adolescents with Autism Spectrum Disorder experience with regard to physical activity participation
Time frame: One-on-one in-depth interviews for wave 1 participants will take place according to the adolescent's preference: online (chat) interview or face to face interview. An average duration of 45 minutes for each interview will be expected.
Semi-structured interviews will be used to explore the barriers and facilitators adolescents with Autism Spectrum Disorder experience with regard to physical activity participation. The interview manual is designed with questions targeting all levels of the socio-ecological model.
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 26 Jun 2024.
- Short description of the research project on the Leuven Autism Research group webpageLink provided by the sponsor.
- Information regarding the Leuven Autism Research groupLink provided by the sponsor.
- 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.
Tine Van Damme principal investigator
KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 6 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Concurrent validity of the Physical Activity Vital Sign (questionnaire) and an Online Physical Activity Logbook (m-Path app) by using accelerometry (Actigraph model wGT3X-BT) as the criterion measure in adolescents with Autism Spectrum Disorder (time frame: Wave 1 participants will wear the accelerometers for seven consecutive days. After, they will be asked to fill out the PAVS. Next, wave 1 participants will wear the accelerometers again for 7 consecutive days and will fill out the OPAL.). The study lists 5 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 26 Jun 2024.