Exercise Training in Children With Communication Impairments

May 16, 2025 updated by: Marquette University

Exercise as Treatment in Children With Communication Impairments

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
This group will receive treatment 3x/week for 6 weeks
Behavioral: Exercise
Participants will participate in cardiovascular, agility, balance, strength and coordination training.
Sham Comparator: Restful Play
This group will receive treatment 3x/week for 6 weeks.
Behavioral: Restful Play
This group will engage in restful play activities such as coloring and playing with legos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: pre-treatment, immediately post-treatment, follow-up (4 and 12 weeks following completion of treatment)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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).
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
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.
pre-treatment, immediately post-treatment
Enjoyment of Intervention
Time Frame: Immediately post each treatment session (n = 18) up to 6 weeks.
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.
Immediately post each treatment session (n = 18) up to 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marquette University

Collaborators

University of Arizona

Investigators

  • Principal Investigator: Jenya Iuzzini-Seigel, PhD, Marquette University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 76117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual level data will be shared

IPD Sharing Time Frame

Beginning 6 months after publication. No end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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