- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04950517
Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder (PAASD)
Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder: Reliability, Validity and Correlates
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- Anke Arkesteyn
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Leuven, Belgium
- UPC Z.Org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Written informed consent/assent
- ASD diagnosis according to the DSM-IV/5
- Proficient knowledge of Dutch
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Wave 1 participants
The study consists of three work packages.
Wave 1 participants will be included in all work packages.
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Wave 2 participants
The study consists of three work packages.
Wave 2 participants will only be recruited for work package 2.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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(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).
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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).
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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.
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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. |
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.
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Collaborators and Investigators
Investigators
- Principal Investigator: Tine Van Damme, KU Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S65474
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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