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Physical Exercise and Contributors to Academic Performance Among Adolescents With ASD (Fit Club Study) (FitClub)

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ClinicalTrials.gov Identifier: NCT03934879
Recruitment Status : Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
This study, Physical Exercise and Contributors to Academic Performance among Adolescents with Autism Spectrum Disorders (ASD), aims to expand our understanding of the impact of regular physical exercise on improvement in academic performance. The investigators will focus on the use of affordable, portable, and achievable interventions that can be easily shared and incorporated into other academic and home settings. The study will examine the use a regular vigorous exercise program for helping students with ASD reduce body mass index and improve executive function, motor performance, sensory responsiveness, and mood. The investigators propose a collaborative arrangement with an area school to conduct an 18-month exploratory pilot study of 30 middle- and high-school aged students (12 to 18 years old) with ASD, who are returning participants or are new to participating in the Fit Club at Gateway Academy. The investigators expect that the changes elicited by participation in this type of exercise program will support the formation of adult life skills, impacting on long-term quality of life for individuals with ASD and children with other conditions.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: FitClub Other: Regular School Activities Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One school will receive FitClub intervention. Second school will receive regular school activities.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Exercise and Contributors to Academic Performance Among Adolescents With ASD (Fit Club Study)
Actual Study Start Date : August 2016
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gateway Academy
For this study, Gateway Academy students will participate in the FitClub intervention. They will rotate through each fitness module, which includes spin class, Pilates, strengthening exercises (weight training), basketball, running and rhythm, and cardio fitness. Students will meet five days per week during their first class of the day for 35 minutes and participate in two randomly assigned modules for two week periods. After 2 weeks, they participate in 2 different modules. Resting and peak heart rate (during exercise), calories burned and steps taken will be collected during each session.
Behavioral: FitClub
Participants will rotate through each fitness module, which includes spin class, Pilates, strengthening exercises (weight training), basketball, running and rhythm, and cardio fitness. Students will meet five days per week during their first class of the day for 35 minutes and participate in two randomly assigned modules for two week periods. After 2 weeks, they participate in 2 different modules. Resting and peak heart rate (during exercise), calories burned and steps taken will be collected during each session.

Active Comparator: Control School
Other comparable school will be added as a control school, in which regular school activities will be provided.
Other: Regular School Activities
Students will participate in regular school activities.




Primary Outcome Measures :
  1. Change from baseline in Bruininks-Osteretsky Test of Motor Proficiency, Second Edition [ Time Frame: Initial, 9 months ]
    is a standardized measure of motor proficiency. It generates gender-specific composite subscale scores for: fine manual control, manual coordination, body coordination, strength and agility, and a full motor composite score, and has been normed for children between ages 4 and 21. Participants will be tested at the beginning and end of the school year to detect change in motor proficiency after participating in the intervention.


Secondary Outcome Measures :
  1. Change from baseline in Adolescent and Young Adult Activity Card Sort [ Time Frame: Initial, 9 months ]
    is a card sort assessment of participation in everyday activities developed for individuals between the ages of 18-25. It includes activities in categories of obligatory chores, leisure, social, health, wellness or fitness, education and learning, work, and parenting/caring for children. Participants will be tested at the beginning and end of the school year to detect change in activity participation after participating in the intervention.

  2. Change from baseline in Depression, Anxiety and Stress Scale [ Time Frame: Initial, 9 months ]
    is a self-report, 4-point Likert-scale and a quantitative measure of distress along three dimensions: depression, anxiety and stress. Participants will be tested at the beginning and end of the school year to detect change.

  3. Change from baseline in Repetitive Behavior Scale [ Time Frame: Initial, 9 months ]
    An empirically derived parent-reported clinical rating scale for measuring the presence and severity of a variety of forms of restricted, repetitive behaviors that are characteristic of children and adults with Autism Spectrum Disorders (ASD). Six subscales are derived from 43 items consisting of: 1) Stereotyped Behavior, 2) Self-injurious Behavior, 3) Compulsive Behavior, 4) Routine Behavior, 5) Sameness Behavior, and 6) Restricted Behavior. This scale will be administered at the beginning and the end of the school year to detect changes in repetitive behavior from participation in the intervention.

  4. Change from baseline in Sensory Profile Adolescent/Adult [ Time Frame: Initial, 9 months ]
    is a standardized questionnaire for individuals between the ages of 11 and 65, is comprised of 60 statements rated on a Likert (1) never to (5) always scale. Participants will be complete the form at the beginning and end of the school year to detect change in their sensory responsiveness after participating in the intervention.

  5. Change from baseline in Body Mass Indices [ Time Frame: Initial, 9 months ]
    Height and weight will be measured and BMI calculated from that. Height and weight will be measured at the beginning and end of the school year to detect change in BMI after participating in the intervention.

  6. Change from baseline in Exercise Heart Rate [ Time Frame: initial, 9 months ]
    FitbitChargeHR® activity tracking wristband with a HR monitor and wireless syncing capabilities will be worn by participants and will be used to track resting and peak HR. Exercise heart rate will be compared between the beginning and the end of the school year to detect changes after participating in the intervention.

  7. Change from baseline in Delis-Kaplan Executive Function System [ Time Frame: Initial, 9 months ]
    is the first nationally standardized set of tests to evaluate higher level cognitive. Participants will be tested at the beginning and end of the school year to detect change in executive function after participating in the intervention.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 12 - 18 years
  • Diagnosis of ASD
  • IQ of 60+, will be provided by Gateway Academy with parental consent
  • Willingness to participate in study (i.e. signed assent/consent)
  • Conversational use of English language

Exclusion Criteria:

  • Dual diagnosis of cerebral palsy or any other major neurologic condition
  • Uncorrected hearing or vision problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934879


Locations
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United States, Texas
Gateway Academy
Houston, Texas, United States, 77092
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Claudia L Hilton, PhD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03934879     History of Changes
Other Study ID Numbers: 16-0185
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders