Exercise Training in Children With Communication Impairments
ConditionDevelopmental Language Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-9
SponsorMarquette University
About this trial
This clinical trial study has two goals. The first goal is to establish fitness levels, participation in physical activities, and fine/gross motor abilities for children with development language disorder (DLD). DLD occurs in 1/13 children and children with DLD often have poorer fine/gross motor skills than those with typical development. The second goal is to determine whether physical exercise helps children with DLD and typical development to learn better and improve fitness and fine/gross motor abilities more than participating in restful play activities.
All children (DLD and typically developing) will undergo communication, fine/gross motor and fitness testing. Children will be randomly assigned to participate in an exercise program (n =20) or to a restful play program (n = 20). Both programs will take place 3x/week for 6 weeks and children will only participate in one of the two programs.
Children in the exercise program will do activities to train cardiovascular fitness, agility, balance, strength, and endurance while children in the restful play condition will do things like play with legos and color.
Researchers will compare changes in learning tasks and fitness levels for children (DLD and typically developing) who participated in the exercise program vs. restful play program.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(1) between 5 and 9 years old at enrollment
(2) from homes where the primary language spoken is English
(3) normal hearing based on parent report and audiometric screening
(4) typical nonverbal cognition as determined by a T-score within 1.5 standard deviations of the mean on nonverbal subtests of the Reynolds Intellectual Assessment Scales
Disqualifiers
(1) diagnosis of disorder that significantly affects social interactions (e.g., autism), as per referral diagnosis or which is identified during initial screening or assessment phase
(2) vision impairments that prevent participation in our experimental protocol
(3) inability for any reason to participate in assessment and/or treatment protocols
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralParticipants will participate in cardiovascular, agility, balance, strength and coordination training.
Restful Play
BehavioralThis group will engage in restful play activities such as coloring and playing with legos.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ExerciseExperimental treatment 1 intervention
Group B: Restful PlaySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes to cognitive-linguistic performance: Word learning accuracy (% correct)
Participants will complete a word learning task in which they are taught novel words and then tested on their recognition of the novel words. Accuracy on this task will be assessed at various time points. This task has previously been used to test effects of a brief bout of exercise (3 minutes) on word learning accuracy for children in the same age range.
Time frame
Pre-treatment, immediately post-treatment, and follow-up (4 and 12 weeks following completion of treatment)2
Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds)
The Serial Reaction Time task is a procedural learning task that tests learning of a 5-step visuospatial sequence. It has previously been used to demonstrate procedural learning gains and differences in children with childhood apraxia of speech, phonological disorder, language disorder, and typical development.
Time frame
pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)Secondary outcomes
1
Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min)
VO2 max (ml/kg/min) will be used to establish fitness level to address Aim 1 and will be used to measure changes to fitness for Aim 2. This will be collected based on performance on the Progressive Aerobic Cardiovascular Endurance Run (PACER).
Time frame
pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)2
Motor Performance (scaled scores)
Motor Performance on the Movement Assessment Battery for Children, which yields scaled component scores for manual dexterity, balance, and aiming and catching. Each component score has a mean of 10 with scores below 7 indicating performance below the age-expected typically developing range.
Time frame
pre-treatment, immediately post-treatment3
Enjoyment of Intervention
Enjoyment will be measured on a 5-point smiley face pictorial likert scale that ranges from negative to neutral to positive. Children will complete this following each intervention session.
Time frame
Immediately post each treatment session (n = 18) up to 6 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Marquette University
Lead sponsor
University of Arizona
Collaborator
Source ClinicalTrials.gov