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

NCT03934879 | Completed DMC

• 1 other identifier: 16-0185
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Bruininks-Osteretsky Test of Motor Proficiency, Second Edition

  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.

  Initial, 9 months

Secondary Outcomes (7)

• Change from baseline in Adolescent and Young Adult Activity Card Sort

  Initial, 9 months

• Change from baseline in Depression, Anxiety and Stress Scale

  Initial, 9 months

• Change from baseline in Repetitive Behavior Scale

  Initial, 9 months

• Change from baseline in Sensory Profile Adolescent/Adult

  Initial, 9 months

• Change from baseline in Body Mass Indices

  Initial, 9 months

Study Arms (2)

Gateway Academy

EXPERIMENTAL

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

Control School

ACTIVE COMPARATOR

Other comparable school will be added as a control school, in which regular school activities will be provided.

Other: Regular School Activities

Interventions

FitClub BEHAVIORAL

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.

Gateway Academy

Regular School Activities OTHER

Students will participate in regular school activities.

Control School

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Gateway Academy

Houston, Texas, 77092, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Claudia L Hilton, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One school will receive FitClub intervention. Second school will receive regular school activities.

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: May 2, 2019
• Study Start: August 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2020
• Last Updated: February 1, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)