Exercise Training in Children With Communication Impairments

NCT06340893 | Recruiting

• 1 other identifier: 76117
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Language Disorder

Keywords

developmental language disorder; exercise; learning; word learning; fitness

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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.

  pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)

Secondary Outcomes (3)

• Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min)

  pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)

• Motor Performance (scaled scores)

  pre-treatment, immediately post-treatment

• Enjoyment of Intervention

  Immediately post each treatment session (n = 18) up to 6 weeks.

Study Arms (2)

Exercise

EXPERIMENTAL

This group will receive treatment 3x/week for 6 weeks

Behavioral: Exercise

Restful Play

SHAM COMPARATOR

This group will receive treatment 3x/week for 6 weeks.

Behavioral: Restful Play

Interventions

Exercise BEHAVIORAL

Participants will participate in cardiovascular, agility, balance, strength and coordination training.

Exercise

Restful Play BEHAVIORAL

This group will engage in restful play activities such as coloring and playing with legos.

Restful Play

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• Marquette University: lead
• University of Arizona: collaborator

Study Sites (1)

Marquette U

Milwaukee, Wisconsin, 53201, United States

RECRUITING

Related Publications (17)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Hillman CH, Pontifex MB, Raine LB, Castelli DM, Hall EE, Kramer AF. The effect of acute treadmill walking on cognitive control and academic achievement in preadolescent children. Neuroscience. 2009 Mar 31;159(3):1044-54. doi: 10.1016/j.neuroscience.2009.01.057. Epub 2009 Feb 3.

  PMID: 19356688 BACKGROUND

• Ullman MT, Pierpont EI. Specific language impairment is not specific to language: the procedural deficit hypothesis. Cortex. 2005 Jun;41(3):399-433. doi: 10.1016/s0010-9452(08)70276-4.

  PMID: 15871604 BACKGROUND

• Alt M, Gray S, Hogan TP, Schlesinger N, Cowan N. Spoken Word Learning Differences Among Children With Dyslexia, Concomitant Dyslexia and Developmental Language Disorder, and Typical Development. Lang Speech Hear Serv Sch. 2019 Oct 10;50(4):540-561. doi: 10.1044/2019_LSHSS-VOIA-18-0138. Epub 2019 Oct 10.

  PMID: 31600465 BACKGROUND

• Braaksma P, Stuive I, Garst RME, Wesselink CF, van der Sluis CK, Dekker R, Schoemaker MM. Characteristics of physical activity interventions and effects on cardiorespiratory fitness in children aged 6-12 years-A systematic review. J Sci Med Sport. 2018 Mar;21(3):296-306. doi: 10.1016/j.jsams.2017.07.015. Epub 2017 Jul 20.

  PMID: 28899655 BACKGROUND

• Pruitt M, Morini G. Examining the Role of Physical Activity on Word Learning in School-Aged Children. J Speech Lang Hear Res. 2021 May 11;64(5):1712-1725. doi: 10.1044/2021_JSLHR-20-00359. Epub 2021 Apr 28.

  PMID: 33909448 BACKGROUND

• Hall, L., Hume, C., & Tazzyman, S. (2016, June). Five degrees of happiness: Effective smiley face likert scales for evaluating with children. In Proceedings of the the 15th international conference on interaction design and children (pp. 311-321).

  BACKGROUND

• Leger LA, Lambert J. A maximal multistage 20-m shuttle run test to predict VO2 max. Eur J Appl Physiol Occup Physiol. 1982;49(1):1-12. doi: 10.1007/BF00428958.

  PMID: 7201922 BACKGROUND

• Nissen, M. J., & Bullemer, P. (1987). Attentional requirements of learning: Evidence from performance measures. Cognitive psychology, 19(1), 1-32.

  BACKGROUND

• Wagner MO, Kastner J, Petermann F, Bos K. Factorial validity of the Movement Assessment Battery for Children-2 (age band 2). Res Dev Disabil. 2011 Mar-Apr;32(2):674-80. doi: 10.1016/j.ridd.2010.11.016. Epub 2010 Dec 13.

  PMID: 21146955 BACKGROUND

MeSH Terms

Conditions

Language Development Disorders; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jenya Iuzzini-Seigel, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenya Iuzzini-Seigel, PhD

CONTACT

414-288-1529; jenya.iuzzini-seigel@marquette.edu

Danielle Rice

CONTACT

danielle.rice@marquette.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group and will be different to those conducting the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to the exercise intervention group or to the restful play (sham) condition.

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 2, 2024
• Study Start: July 2, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal and evidence of ethical conduct of research and appropriate institutional oversight (e.g., IRB). Proposals should be directed to jenya.iuzzini-seigel@marquette.edu. To gain access, data requestors will need to complete and sign a data sharing agreement.

Locations

US (1)