Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03934879 |
| Other study ID # |
16-0185 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2016 |
| Est. completion date |
December 2020 |
Study information
| Verified date |
April 2020 |
| Source |
The University of Texas Medical Branch, Galveston |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
