Optimal Method for Tongue Strengthening

Focus of Study is Tongue Strength Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809558
• Other study ID #: EXPD-HP-20-F-5
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: December 2022
• Source: Samford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Focus of Study is Tongue Strength

Intervention

Behavioral:
• Tongue resistance exercise
Participant will complete tongue resistance exercises.

Locations

Country	Name	City	State
United States	Samford University	Birmingham	Alabama

Sponsors (5)

Lead Sponsor	Collaborator
Samford University	Case Western Reserve University, Emerson College, James Madison University, Texas Christian University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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