Samford University
Birmingham, Alabama, 35229, United States
NCT Number: NCT04809558
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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Notify Me55 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35229, United States
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:
Secondary Research Questions:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participant will complete tongue resistance exercises.
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)
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)
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)
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.
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.
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
Samford University
Other
Determining an Optimal Delivery Method for Tongue Strengthening During Swallowing Rehabilitation: Building a Framework for Clinical Practice
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