Clinical trial NCT04950517: Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder
Official title: Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder: Reliability, Validity and Correlates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: Physical activity
Adolescents
Cardiorespiratory fitness
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 76
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

1. 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.
2. 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.
3. 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:

1. To examine the concurrent validity of two self-report PA instruments and the concurrent validity and test-retest reliability of a submaximal CRF test.
2. To determine potential complex and multiple (interactions between) correlates of PA, using a comprehensive assessment protocol.
3. To explore the perspectives of adolescents with ASD concerning the barriers and facilitators of PA participation.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 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.
measure: Concurrent validity of a submaximal cardiorespiratory fitness test in adolescents with Autism Spectrum Disorder
timeFrame: 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.
measure: The test-retest reliability of a submaximal cardiorespiratory fitness test in adolescents with Autism Spectrum Disorder
timeFrame: 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.
measure: 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
timeFrame: 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).
measure: Exploration of the barriers and facilitators adolescents with Autism Spectrum Disorder experience with regard to physical activity participation
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Anke Arkesteyn
city: Leuven
country: Belgium
facility: UPC Z.Org
Study officials:
affiliation: KU Leuven
name: Tine Van Damme
role: PRINCIPAL_INVESTIGATOR
References: