Clinical trial NCT06340893: Exercise Training in Children With Communication Impairments
Official title: Exercise as Treatment in Children With Communication Impairments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Language Disorder
Keywords: developmental language disorder
exercise
learning
word learning
fitness
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: University of Arizona
First posted: 2024-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the exercise intervention group or to the restful play (sham) condition.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Communication impairments affect \~10% of children in the US between 3-10 years of age, and fine/gross motor deficits co-occur in an astounding 30-85% of this population. One subpopulation that evidences high rates of co-occurring language and motor deficits is children with developmental language disorder (DLD; a highly common disorder that affects expressive and/or receptive language in 1/13 children). Consequently, millions of children present with these debilitating impairments that require time-consuming and costly therapy, which typically occurs in discipline-specific silos. The siloed approach has limitations as it fails to leverage potentially synergistic effects that may be achieved when the whole child is treated, rather than intervene discipline by discipline.

Alternative, ground-shifting interventions that harness neuroplasticity and yield multisystem gains are needed to fill this gap in treatment options for children with co-occurring language and motor deficits.

The goal of the proposed research is two-fold. The Aim 1 study will establish motor performance and fitness levels for children with DLD and carefully characterize the motor deficits of children in this population. The Aim 2 study is a Phase 0/Early Phase 1 random control trial (RCT) that tests the efficacy of physical exercise as treatment to promote cognitive-linguistic and fitness gains in children with DLD. Participants will be randomly assigned to undergo 6 weeks (3x/week) of exercise training (i.e., activities to train cardiovascular fitness, agility, balance, strength, endurance) or to a restful play condition (e.g., legos and coloring) on the same schedule. Both interventions will be provided in small groups. Cognitive-linguistic and fitness will be assessed pre-treatment and again immediately post treatment and at 1-month, and 3-months post treatment to determine treatment and maintenance gains on these measures.

This research will gather vital information for a Phase 2 trial of preliminary efficacy and contribute high-quality evidence that will help speech language pathologists and other practitioners make evidence-based clinical decisions. The long-term goal of this research program is to identify the breadth of comorbid impairments in children with communication disorders and develop optimally effective treatments to maximize outcomes and quality of life for the millions of children and families coping with communication impairments.

Eligibility criteria: Inclusion Criteria:

Children with a diagnosis of developmental language disorder (DLD) or typically developing controls will be included.

All children will meet following inclusion criteria:

* (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

Exclusion Criteria:

Exclusionary Criteria are:

* (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

Primary outcomes:
measure: Changes to cognitive-linguistic performance: Word learning accuracy (% correct)
timeFrame: Pre-treatment, immediately post-treatment, and follow-up (4 and 12 weeks following completion of treatment)
measure: Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds)
timeFrame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
Secondary outcomes:
measure: Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min)
timeFrame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
measure: Motor Performance (scaled scores)
timeFrame: pre-treatment, immediately post-treatment
measure: Enjoyment of Intervention
timeFrame: Immediately post each treatment session (n = 18) up to 6 weeks.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette U
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Jenya Iuzzini-Seigel, PhD
role: PRINCIPAL_INVESTIGATOR
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