Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder

NCT04950517 | Completed

• 1 other identifier: S65474
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

Physical activity; Adolescents; Cardiorespiratory fitness

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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).

  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.

  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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Written informed consent/assent
• ASD diagnosis according to the DSM-IV/5
• Proficient knowledge of Dutch

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

Anke Arkesteyn

Leuven, 3000, Belgium

Location

UPC Z.Org

Leuven, Belgium

Location

Related Links

• Short description of the research project on the Leuven Autism Research group webpage
• Information regarding the Leuven Autism Research group

MeSH Terms

Conditions

Autism Spectrum Disorder; Motor Activity

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Tine Van Damme

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 6, 2021
• Study Start: November 18, 2021
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)