Clinical trial NCT04809558: Optimal Method for Tongue Strengthening
Official title: Determining an Optimal Delivery Method for Tongue Strengthening During Swallowing Rehabilitation: Building a Framework for Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study is Tongue Strength
Lead sponsor: Samford University
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Emerson College
name: James Madison University
name: Texas Christian University
First posted: 2021-03-22
Enrollment: 87
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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?

Eligibility criteria: 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 Tongueometer™ use)
* Past or present pain disorders involving the jaw or mandible (e.g., TMJ disorder, myofascial pain disorder) (contraindication for Tongueometer™ 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

Primary outcomes:
measure: Change in maximum isometric tongue pressure (MIP)
timeFrame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
measure: Change in regular effort saliva swallow pressure (RESS)
timeFrame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
measure: Change in effortful swallow pressure (ESP)
timeFrame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
Secondary outcomes:
measure: Change in participant-perceived motivation for assigned exercise regimen
timeFrame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
measure: Change in participant-perceived confidence for assigned exercise regimen
timeFrame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
measure: Exercise adherence tracking
timeFrame: Collected at Weeks, 2, 4, 6, 8; and 1-month post if participant was randomized to a maintenance program
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Samford University
state: Alabama
Study officials:
affiliation: Samford University
name: Sarah H Szynkiewicz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: James Madison University
name: Erin Kamarunas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Christian University
name: Teresa Drulia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emerson College
name: Lindsay Griffin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Rachel Mulheren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.