Optimal Method for Tongue Strengthening

Determining an Optimal Delivery Method for Tongue Strengthening During Swallowing Rehabilitation: Building a Framework for Clinical Practice

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.

Study Overview

• Status: Completed
• Conditions: Focus of Study is Tongue Strength
• Intervention / Treatment: Behavioral: Tongue resistance exercise

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?

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah H Szynkiewicz, Ph.D.; Phone Number: 205-726-4579; Email: sszynkie@samford.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35229
      • Samford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Max intensity with no visual biofeedback; Tongue resistance exercises completed at maximum intensity with no visual biofeedback.	Behavioral: Tongue resistance exercise; Participant will complete tongue resistance exercises.
Active Comparator: Progressive intensity with no visual biofeedback.; Tongue resistance exercises completed at a progressive intensity with no visual biofeedback.	Behavioral: Tongue resistance exercise; Participant will complete tongue resistance exercises.
Active Comparator: Max intensity with visual biofeedback; Tongue resistance exercises completed at maximum intensity with visual biofeedback of performance.	Behavioral: Tongue resistance exercise; Participant will complete tongue resistance exercises.
Active Comparator: Progressive intensity with visual biofeedback.; Tongue resistance exercises completed at a progressive intensity with visual biofeedback of performance.	Behavioral: Tongue resistance exercise; Participant will complete tongue resistance exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Samford University
• Collaborators: Texas Christian University; Case Western Reserve University; Emerson College; James Madison University
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: EXPD-HP-20-F-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No