Optimal Method for Tongue Strengthening

NCT ID: NCT04809558

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-08-15

Brief Summary

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The research team will conduct a multi-site, randomized controlled trial examining the effectiveness of exercise intensity progression compared to standard practice (no progression) in the context of swallowing rehabilitation. The study will also determine the impact of using biofeedback during resistance training on tongue strength. The study is a first step in determining an optimal delivery of tongue strengthening exercise in typically aging older persons, with the plan to develop a framework for guiding clinical practice of tongue strengthening in various dysphagic populations. Participants will be randomized into one of four treatment groups and complete 8 weeks of tongue resistance training.

Detailed Description

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Rehabilitative exercises have been central to dysphagia (swallowing difficulty) treatment for decades, with the goal to increase strength, endurance, and/or coordination of the muscles responsible for swallowing. With any exercise-based therapy, an understanding of dosing is critical to optimize outcomes and to avoid over- or under-prescribing exercise, which can have a negative effect. For example, overtraining can lead to reductions in strength, which may put patients who are completing a swallowing rehabilitation program at increased risk. Therefore, it is important to develop dosing recommendations specific to swallowing musculature. Clinical practice remains unguided in terms of whether a progressive or maximum intensity, both common forms of rehabilitative exercise for dysphagic patients, should be used for lingual resistance training. Speech-Language Pathologists (SLP) currently base these decisions on preference and experience; however, research is desperately needed in this area to support and guide clinical decisions. The investigators aim to fill this gap in evidence by determining an optimal dosing for tongue strengthening in older persons. It is anticipated that the study findings will directly influence clinical decisions in both inpatient rehabilitation facilities and home health post-acute care settings, and ultimately improve patient outcomes in the area of swallowing. This study represents the start of a research program intended to provide significant information on optimal delivery of tongue strengthening exercise in various populations with difficulty swallowing.

To determine an optimal delivery method for tongue resistance training in healthy older persons by examining how intensity progression and biofeedback impacts tongue strength, participant motivation, and program adherence. The data collected in this initial study will inform future studies designed to develop a framework for guiding clinical practice with SLPs prescribing tongue strengthening exercise to patients with swallowing issues.

Primary Research Questions:

* Is tongue strength impacted by exercise resistance intensity when comparing progressive resistance to maximum resistance?
* Is tongue strength impacted by visual biofeedback during tongue resistance training?

Secondary Research Questions:

* Is participant motivation impacted by progressive intensity exercise when compared to maximum intensity exercise?
* Is participant motivation impacted by the use of biofeedback when compared to no visual biofeedback?
* Is participant adherence to the exercise program impacted by progressive intensity exercise when compared to maximum intensity exercise?
* Is participant adherence to the exercise program impacted by the use of biofeedback when compared to no visual biofeedback?

Conditions

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Focus of Study is Tongue Strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant will only know exercise instructions for the group he/she is randomized to. Participant will not be provided with information about other groups.

Study Groups

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Max intensity with no visual biofeedback

Tongue resistance exercises completed at maximum intensity with no visual biofeedback.

Group Type ACTIVE_COMPARATOR

Tongue resistance exercise

Intervention Type BEHAVIORAL

Participant will complete tongue resistance exercises.

Progressive intensity with no visual biofeedback.

Tongue resistance exercises completed at a progressive intensity with no visual biofeedback.

Group Type ACTIVE_COMPARATOR

Tongue resistance exercise

Intervention Type BEHAVIORAL

Participant will complete tongue resistance exercises.

Max intensity with visual biofeedback

Tongue resistance exercises completed at maximum intensity with visual biofeedback of performance.

Group Type ACTIVE_COMPARATOR

Tongue resistance exercise

Intervention Type BEHAVIORAL

Participant will complete tongue resistance exercises.

Progressive intensity with visual biofeedback.

Tongue resistance exercises completed at a progressive intensity with visual biofeedback of performance.

Group Type ACTIVE_COMPARATOR

Tongue resistance exercise

Intervention Type BEHAVIORAL

Participant will complete tongue resistance exercises.

Interventions

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Tongue resistance exercise

Participant will complete tongue resistance exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Are age 55 or older
* \< 3 score on Eating Assessment Tool-10 (screening tool for swallowing difficulty)
* \> 24 score on Mini Mental State Examination (screening tool for cognitive impairment)
* Have a normal oral structure as assessed with an oral mechanism screener

Exclusion Criteria

* A history of seizures (contraindication for Tongueometerâ„¢ use)
* Past or present pain disorders involving the jaw or mandible (e.g., TMJ disorder, myofascial pain disorder) (contraindication for Tongueometerâ„¢ use)
* A history of oral surgery (routine dental surgery acceptable)
* A history of neurogenic disorder (e.g., Parkinson's disease)
* A history of swallowing difficulty
* Not being able to complete an 8-week study protocol
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role collaborator

Emerson College

OTHER

Sponsor Role collaborator

James Madison University

OTHER

Sponsor Role collaborator

Texas Christian University

OTHER

Sponsor Role collaborator

Samford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah H Szynkiewicz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samford University

Erin Kamarunas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

James Madison University

Teresa Drulia, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Christian University

Lindsay Griffin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Emerson College

Rachel Mulheren, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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Samford University

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Rhea MR, Alvar BA, Burkett LN, Ball SD. A meta-analysis to determine the dose response for strength development. Med Sci Sports Exerc. 2003 Mar;35(3):456-64. doi: 10.1249/01.MSS.0000053727.63505.D4.

Reference Type BACKGROUND
PMID: 12618576 (View on PubMed)

Kamarunas E, Murray K, Drulia T, Szynkiewicz S, Griffin L, Mulheren R. Biofeedback and Exercise Load Affect Accuracy of Tongue Strength Exercise Performance. Dysphagia. 2025 Apr;40(2):489-500. doi: 10.1007/s00455-024-10751-w. Epub 2024 Aug 18.

Reference Type DERIVED
PMID: 39154305 (View on PubMed)

Other Identifiers

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EXPD-HP-20-F-5

Identifier Type: -

Identifier Source: org_study_id