Optimal Method for Tongue Strengthening

Samford University

Status: Completed

Conditions: Focus of Study is Tongue Strength

Treatments: Behavioral: Tongue resistance exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04809558

EXPD-HP-20-F-5

Details and patient eligibility

About

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.

Full 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?

Enrollment: 87 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 4 patient groups

Max intensity with no visual biofeedback

Active Comparator group

Description:

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

Treatment:

Behavioral: Tongue resistance exercise

Progressive intensity with no visual biofeedback.

Active Comparator group

Description:

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

Treatment:

Behavioral: Tongue resistance exercise

Max intensity with visual biofeedback

Active Comparator group

Description:

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

Treatment:

Behavioral: Tongue resistance exercise

Progressive intensity with visual biofeedback.

Active Comparator group

Description:

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

Treatment:

Behavioral: Tongue resistance exercise