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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| Emerson College | OTHER |
| James Madison University | OTHER |
| Texas Christian University |
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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.
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:
Secondary Research Questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Max intensity with no visual biofeedback | Active Comparator | Tongue resistance exercises completed at maximum intensity with no visual biofeedback. |
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| Progressive intensity with no visual biofeedback. | Active Comparator | Tongue resistance exercises completed at a progressive intensity with no visual biofeedback. |
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| Max intensity with visual biofeedback | Active Comparator | Tongue resistance exercises completed at maximum intensity with visual biofeedback of performance. |
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| Progressive intensity with visual biofeedback. | Active Comparator | Tongue resistance exercises completed at a progressive intensity with visual biofeedback of performance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tongue resistance exercise | Behavioral | Participant will complete tongue resistance exercises. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in maximum isometric tongue pressure (MIP) | MIP in kilopascals (kPa) | Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program |
| Change in regular effort saliva swallow pressure (RESS) | RESS is kilopascals (kPa) | Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program |
| Change in effortful swallow pressure (ESP) | ESP in kilopascals (kPa) | Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant-perceived motivation for assigned exercise regimen | Standardized 0 mm (lowest level of perceived motivation) to 100 mm (highest level of perceived motivation) visual-analog scale participant perception of internal motivation. | Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah H Szynkiewicz, Ph.D. | Samford University | Principal Investigator |
| Erin Kamarunas, Ph.D. | James Madison University | Principal Investigator |
| Teresa Drulia, Ph.D. | Texas Christian University | Principal Investigator |
| Lindsay Griffin, Ph.D. | Emerson College | Principal Investigator |
| Rachel Mulheren, Ph.D. | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samford University | Birmingham | Alabama | 35229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12618576 | Background | 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. | |
| 39154305 | Derived | 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. |
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| OTHER |
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Participant will only know exercise instructions for the group he/she is randomized to. Participant will not be provided with information about other groups.
| Change in participant-perceived confidence for assigned exercise regimen | Standardized 0 mm (lowest level of perceived confidence) to 100 mm (highest level of perceived confidence) visual-analog scale participant perception of internal confidence. | Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program |
| Exercise adherence tracking | Adherence tracking will be completed by asking participants to keep record form logs of sessions completed | Collected at Weeks, 2, 4, 6, 8; and 1-month post if participant was randomized to a maintenance program |