Optimal Method for Tongue Strengthening

NCT04809558 | Completed

• 1 other identifier: EXPD-HP-20-F-5
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Focus of Study is Tongue Strength

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in participant-perceived motivation for assigned exercise regimen

  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

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

• Exercise adherence tracking

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

Study Arms (4)

Max intensity with no visual biofeedback

ACTIVE COMPARATOR

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

Behavioral: Tongue resistance exercise

Progressive intensity with no visual biofeedback.

ACTIVE COMPARATOR

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

Behavioral: Tongue resistance exercise

Max intensity with visual biofeedback

ACTIVE COMPARATOR

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

Behavioral: Tongue resistance exercise

Progressive intensity with visual biofeedback.

ACTIVE COMPARATOR

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

Behavioral: Tongue resistance exercise

Interventions

Tongue resistance exercise BEHAVIORAL

Participant will complete tongue resistance exercises.

Max intensity with no visual biofeedback; Max intensity with visual biofeedback; Progressive intensity with no visual biofeedback.; Progressive intensity with visual biofeedback.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samford University: lead
• Case Western Reserve University: collaborator
• Emerson College: collaborator
• James Madison University: collaborator
• Texas Christian University: collaborator

Study Sites (1)

Samford University

Birmingham, Alabama, 35229, United States

Location

Related Publications (2)

• 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.

  PMID: 12618576 BACKGROUND

• 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.

  PMID: 39154305 DERIVED

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will only know exercise instructions for the group he/she is randomized to. Participant will not be provided with information about other groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 22, 2021
• Study Start: June 1, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: November 22, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)