Exercise Training in Children With Communication Impairments

Official title

Exercise as Treatment in Children With Communication Impairments

Overview

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.

Interventions

• Behavioral Exercise
  Participants will participate in cardiovascular, agility, balance, strength and coordination training.
• Behavioral Restful Play
  This group will engage in restful play activities such as coloring and playing with legos.

Primary outcome measures

• Changes to cognitive-linguistic performance: Word learning accuracy (% correct) [Time frame: Pre-treatment, immediately post-treatment, and follow-up (4 and 12 weeks following completion of treatment)]
• Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds) [Time frame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)]

Secondary outcome measures (3)

• Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min) [Time frame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)]
• Motor Performance (scaled scores) [Time frame: pre-treatment, immediately post-treatment]
• Enjoyment of Intervention [Time frame: Immediately post each treatment session (n = 18) up to 6 weeks.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Marquette U — Milwaukee

Publications

• Iuzzini-Seigel J, Moorer L, Tamplain P. An Investigation of Developmental Coordination Disorder Characteristics in Children With Childhood Apraxia of Speech. Lang Speech Hear Serv Sch. 2022 Oct 6;53(4):1006-1021. doi: 10.1044/2022_LSHSS-21-00163. Epub 2022 Aug 30. PMID 36041512
• Iuzzini-Seigel J. Motor Performance in Children With Childhood Apraxia of Speech and Speech Sound Disorders. J Speech Lang Hear Res. 2019 Sep 20;62(9):3220-3233. doi: 10.1044/2019_JSLHR-S-18-0380. Epub 2019 Sep 3. PMID 31479382
• Iuzzini-Seigel J. Procedural Learning, Grammar, and Motor Skills in Children With Childhood Apraxia of Speech, Speech Sound Disorder, and Typically Developing Speech. J Speech Lang Hear Res. 2021 Apr 14;64(4):1081-1103. doi: 10.1044/2020_JSLHR-20-00581. Epub 2021 Mar 30. PMID 33784194
• Zelaznik HN, Goffman L. Generalized motor abilities and timing behavior in children with specific language impairment. J Speech Lang Hear Res. 2010 Apr;53(2):383-93. doi: 10.1044/1092-4388(2009/08-0204). PMID 20360463
• Castelli DM, Hillman CH, Buck SM, Erwin HE. Physical fitness and academic achievement in third- and fifth-grade students. J Sport Exerc Psychol. 2007 Apr;29(2):239-52. doi: 10.1123/jsep.29.2.239. PMID 17568069
• Kao SC, Westfall DR, Parks AC, Pontifex MB, Hillman CH. Muscular and Aerobic Fitness, Working Memory, and Academic Achievement in Children. Med Sci Sports Exerc. 2017 Mar;49(3):500-508. doi: 10.1249/MSS.0000000000001132. PMID 27776002
• Ludyga S, Gerber M, Kamijo K. Exercise types and working memory components during development. Trends Cogn Sci. 2022 Mar;26(3):191-203. doi: 10.1016/j.tics.2021.12.004. Epub 2022 Jan 11. PMID 35031211
• Haga M. The relationship between physical fitness and motor competence in children. Child Care Health Dev. 2008 May;34(3):329-34. doi: 10.1111/j.1365-2214.2008.00814.x. PMID 18410639

Identifiers

NCT: NCT06340893 · 76117

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗