Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT04809558
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2021-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Method for Tongue Strengthening
Sponsor:
Samford University
Organization:
Study Overview
Official Title:
Determining an Optimal Delivery Method for Tongue Strengthening During Swallowing Rehabilitation: Building a Framework for Clinical Practice
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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?
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?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: