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Completed

NCT Number: NCT04809558

Optimal Method for Tongue Strengthening

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samford University

Birmingham, Alabama, 35229, United States

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tongue resistance exercise

Behavioral

Participant will complete tongue resistance exercises.

Primary outcomes

  1. Change in maximum isometric tongue pressure (MIP)

    Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program

    MIP in kilopascals (kPa)

  2. Change in regular effort saliva swallow pressure (RESS)

    Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program

    RESS is kilopascals (kPa)

  3. Change in effortful swallow pressure (ESP)

    Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program

    ESP in kilopascals (kPa)

Secondary outcomes

  1. Change in participant-perceived motivation for assigned exercise regimen

    Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program

    Standardized 0 mm (lowest level of perceived motivation) to 100 mm (highest level of perceived motivation) visual-analog scale participant perception of internal motivation.

  2. Change in participant-perceived confidence for assigned exercise regimen

    Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program

    Standardized 0 mm (lowest level of perceived confidence) to 100 mm (highest level of perceived confidence) visual-analog scale participant perception of internal confidence.

  3. Exercise adherence tracking

    Time frame: Collected at Weeks, 2, 4, 6, 8; and 1-month post if participant was randomized to a maintenance program

    Adherence tracking will be completed by asking participants to keep record form logs of sessions completed

Sponsors and collaborators

Lead sponsor

Samford University

Other

Collaborators

  • Case Western Reserve University
  • Emerson College
  • James Madison University
  • Texas Christian University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.