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

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FitClub
Regular School Activities
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gateway Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gateway Academy

Control School

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in Adolescent and Young Adult Activity Card Sort
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.
Change from baseline in Depression, Anxiety and Stress Scale
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.
Change from baseline in Repetitive Behavior Scale
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.
Change from baseline in Sensory Profile Adolescent/Adult
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.
Change from baseline in Body Mass Indices
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.
Change from baseline in Exercise Heart Rate
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.
Change from baseline in Delis-Kaplan Executive Function System
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.

Full Information

First Posted
August 8, 2016
Last Updated
January 28, 2021
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03934879
Brief Title
Physical Exercise and Contributors to Academic Performance Among Adolescents With ASD (Fit Club Study)
Acronym
FitClub
Official Title
Physical Exercise and Contributors to Academic Performance Among Adolescents With ASD (Fit Club Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Detailed Description: Background: Individuals with autism spectrum disorders (ASD) typically have social impairment, have difficulty making decisions and problem solving (executive function) and have impaired motor performance. As a result, they are less likely to even live independently, be employed, go to college or get married. Few effective interventions have been found to help with the complex problems of people with ASD who are unable to establish independent lives. The investigators plan to begin the examination of using a regular physically challenging exercise program to support development of executive function (EF) and motor skills among children and young adults with ASD to improve academic behaviors and participation in adult activities. In addition to having social, EF and motor problems, children and young adults with ASD often participate in limited physical activities, enjoy them less than do typically developing (TD) children, are less motivated to participate in physical activities than TD children, experience weight gain from medications, and encounter problems with reduced physical fitness and obesity. Lack of interest or motivation to exercise may make it difficult for them to comply with daily physical activity recommendations. As a result, these students are less likely to be involved in physical activity, enjoy fewer types of leisure activities, and experience limited relationships with peers, which eventually contribute to lower levels of participation in adult activities. Benefits of Physical Activity: Physical exercise has been shown to improve cognitive processes in TD individuals. It has a positive influence on symptoms seen in children and adolescents with ASD, including experiencing reductions in stereotypical behaviors, improved sensory skills and social responsiveness, improved concentration and memory, weight reduction, improved motor skills, improvement in executive function and a reduction in repetitive behaviors. Many of these skills are necessary for adult tasks such as driving, test-taking, employment, and engaging in other purposeful adult activities. The mechanism of improvement in these cognitive functions as a result of physical exercise is thought to be caused by increased cerebral blood flow, up-regulation of neuroprotective growth factors, and the cardiovascular benefits of exercise, which lead to an improvement in the delivery of oxygen and nutrients. It is not clear, however, if the amount of effort during exercise is related to the improvement in cognitive functions. Participation: Participation in activities is how children and young adults develop an understanding of the expectations of society and gain the physical and social skills needed to function and flourish, it plays an important role in a child's or young adult's social development, and it influences long-term mental and physical health. Mood: Having ASD may lead to psychosocial impairments, including depression, anxiety, stress, and low self-esteem. For example, Shtayermman (2008) reported that 50% of study participants with Asperger syndrome had made a suicide attempt, while Paquette-Smith, Weiss, and Lunsky (2014) determined that "36% suicide attempt rate reported in their sample of 50 adults with Asperger Syndrome was much higher than the national average of 4.6% over a lifetime in the general population". Using the Depression, Anxiety, and Stress Scale (DASS-21), components of psychosocial well-being will be assessed in this cohort of children during this study. Sensory Responsiveness: Children and young adults with ASD demonstrate unusual sensory responses to stimuli more frequently than do typically developing peers or those with other developmental disorders. In a study comparing children with and without ASD, atypical sensory responsiveness patterns greater than one standard deviation from the mean were found in up to 95% in children with ASD, compared to 12 to 25% of children without ASD in the various sensory domains. Gateway Academy: For this study, the investigators will partner with Gateway Academy, a private school that utilizes innovative approaches to learning, physical fitness, and social awareness, and enrolls approximately 55 students of middle to high school age with social and academic challenges, the majority of whom have an ASD diagnosis. Gateway Academy developed a Fit Club fitness program seven years ago modeled after an exercise program developed by Ratey. In addition, a second school, closely matched to Gateway Academy functional levels, has communicated an interest in participating in the second stage of this study. Methodology: Each year, 10 to 15 new students join Gateway Academy who have not participated in an organized, mandatory exercise intervention (Fit Club). With this study, the investigators plan to examine the impact of the Fit Club intervention by comparing students new to the Fit Club intervention throughout the school year, and also by tracking returning students on a range of factors, including BMI, executive function, motor skills, sleep patterns, and classroom behaviors. The investigators propose to conduct an 18-month exploratory pilot study of 30 middle- and high-school aged students (12 to 18 years old) with ASD, who participate in, or are new to participating in the Fit Club at Gateway Academy. Engagement in exercise and response to exercise will be constantly monitored for participants. Other participant data will be collected three times, once at baseline, at the end of the school year, and at the beginning of the next school year. The investigators will adhere to the Fit Club fitness program protocol. All students 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. Study Objectives: Objective 1: To determine how students new to the fitness program compare to their returning peers in BMI, executive function, sensory responsiveness, motor skills, mood, and activity participation. Objective 2: To quantify the changes in BMI, executive function, sensory responsiveness motor skills, and mood after participation in a fitness program after one and two semesters for new and returning students. Objective 3: To determine if greater physical effort is correlated with greater improvement in BMI, executive function, sensory responsiveness, motor skills, and mood. Objective 4: To determine if leisure activity participation patterns vary across ages of students and change after two semesters of participation in a fitness program. Data Collection phase of the study. Timeline Months 1 & 2: Identification of participants, Consents, Baseline data collected (Visit 1) Months 3-9: Fit Club Month 9 (Visit 2) Months 10-12: Summer Break Months13-14: School Start data collection (Visit 3) Months14-18: Data analysis and dissemination Evaluation/Data Analysis: Data from students will include factors that affect academic performance, including measures of EF, sensory responsiveness, and motor skills. Physiological statistics such as height and weight will be collected to calculate Body Mass Indices (BMI) for each participant over the course of the study. To achieve the greatest validity, assessments have been selected that obtain the perspectives from several sources: parent/LAR report, teacher report and direct observation. Parent, student, and teacher questionnaires will be administered online. All students, teachers, and parents will be able to use computers with access to the internet. Observation assessments will be conducted by graduate occupational therapy students from the University of Texas Medical Branch. A FitBit® activity tracking wristband with a heart rate monitor and wireless syncing capabilities will be worn by participants and will be used to track resting and peak heart rate, calories burned, steps taken, and sleep quality. Outcome constructs and performance measures are listed below. Study Outcome: Performance Measure ASD Severity: Social Responsiveness Scale, Second Edition, parent and teacher forms (SRS-2), Sensory Responsiveness: Adolescent/Adult Sensory Profile, Motor Performance: Bruininks-Osteretsky Test of Motor Proficiency, Second Edition (BOT-2), Executive Function: Behavior Rating Inventory of Executive Function, parent and teacher forms (BRIEF), Delis-Kaplan Executive Function System (D-KEFS), Participation: Children's Assessment of Participation and Enjoyment & Preferences for Activities of Children (CAPE/PAC), Life Participation for Parents, Adolescent and Young Adult Activity Card Sort (AYA-ACS), Behavior/Mood: Repetitive Behavior Scale, Depression, Anxiety and Stress Scale (DASS), Effort:Heart Rate and daily steps taken with activity monitoring wristband, Summer Exercise Questionnaire Metabolic Parameters Height and weight scale, Height in inches, Body temperature with no contact thermometer Significance: This research has the potential to change policy regarding physical education for students with ASD. If the results of this study show a strong relationship between the level of physical exertion and improvements in factors affecting academic performance, it will suggest adding more physically exerting activities to school curricula for students with ASD. The positive impact of physical exercise has been observed in previous studies, but this study may help to clarify the relationship between effort during exercise and improvements in the factors that support academic performance. The investigators may also gain understanding of the duration and effort of exercise necessary to see improvements in these factors, and whether the benefits are sustained. Examination of regression from non-adherence over the summer will help clarify the necessity of continuous participation. If a relationship is found between effort and the factors supporting academic performance, it will help to better identify options for interventions to improve those factors in students with ASD. Participation data will build a better understanding of leisure activity participation patterns in adolescents with ASD that will help to guide intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One school will receive FitClub intervention. Second school will receive regular school activities.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gateway Academy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control School
Arm Type
Active Comparator
Arm Description
Other comparable school will be added as a control school, in which regular school activities will be provided.
Intervention Type
Behavioral
Intervention Name(s)
FitClub
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Regular School Activities
Intervention Description
Students will participate in regular school activities.
Primary Outcome Measure Information:
Title
Change from baseline in Bruininks-Osteretsky Test of Motor Proficiency, Second Edition
Description
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.
Time Frame
Initial, 9 months
Secondary Outcome Measure Information:
Title
Change from baseline in Adolescent and Young Adult Activity Card Sort
Description
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.
Time Frame
Initial, 9 months
Title
Change from baseline in Depression, Anxiety and Stress Scale
Description
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.
Time Frame
Initial, 9 months
Title
Change from baseline in Repetitive Behavior Scale
Description
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.
Time Frame
Initial, 9 months
Title
Change from baseline in Sensory Profile Adolescent/Adult
Description
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.
Time Frame
Initial, 9 months
Title
Change from baseline in Body Mass Indices
Description
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.
Time Frame
Initial, 9 months
Title
Change from baseline in Exercise Heart Rate
Description
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.
Time Frame
initial, 9 months
Title
Change from baseline in Delis-Kaplan Executive Function System
Description
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.
Time Frame
Initial, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia L Hilton, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway Academy
City
Houston
State/Province
Texas
ZIP/Postal Code
77092
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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