Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises

Study Overview
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Brief Summary
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The purpose of this study is to learn more about how exercise and protein supply affect swallow muscles. Twenty healthy older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Zoom. During each session, a series of swallow exercises will be performed following a demonstration from a trained speech-language pathologist. Participants will be referred to NYU Langone Health or White Plains Hospital, for a videofluoroscopic swallowing study, acoustic pharyngometry and measures of hand grip strength before and after the treatment protocol. Patients will be able to select their preferred site for swallow study completion. Results will inform the relationship between swallow exercises and pharyngeal muscles. All devices and exercises are established as safe and effective and are FDA approved.

Detailed Description
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The natural next step in this program of research is to investigate interventions for reversing pharyngeal sarcopenia with the ultimate goal of developing novel therapeutic strategies to address this pervasive clinical issue. The exercise science literature suggests that sarcopenia in the limb muscles can be reversed through a combination of rigorous exercise and adequate levels of dietary protein. The innovative multi-disciplinary protocol, PEPP (Pharyngeal Exercises Plus Protein), combines pharyngeal swallowing exercises selected for their known activation of the pharyngeal muscles with daily supplemental protein drinks. The research lab had documented successful improvements to swallowing physiology and pharyngeal sarcopenia in a pilot series of 5 older women using PEPP. However the research was abruptly halted due to both ethical and feasibility challenges posed by the COVID-19 pandemic. In response to these challenges, this study is seeking to establish the feasibility and effectiveness when the PEPP intervention is delivered using telehealth (telePEPP).

Official Title
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Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises

Conditions
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Dysphagia

Intervention / Treatment
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* Other: TelePEPP intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 and older SARC-F score of ≥4 Functional hearing and vision status Access to reliable internet connection Availability of caregiver/family support and/or comfort with independent technology usage Exclusion Criteria: Known structural or neurological causes of dysphagia Not suitable to consume high levels of protein supplementation (i.e. moderate to severe kidney dysfunction)

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Generalized sarcopenia group<br>Older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Webex. During each session, a series of standard of care swallow exercises will be performed following a demonstration from a trained speech-language pathologist. | Other: TelePEPP intervention<br>* TelePEPP sessions will be conducted twice per week by a Speech Language Pathologist and/or graduate student clinician, on the study team. This clinician will deliver the intervention from the NYU Voice Center using the web conferencing software Webex (institutional license) on a Dell desktop computer with a 3.1 GHz intel core processor and high definition camera. Each exercise set will include 40 repetitions (10 reps of effortful swallows, tongue hold swallows, effortful pitch glides and maximal posterior tongue presses). All exercises are widely-adopted by clinicians as standard of care exercises. The number of sets will be gradually increased as tolerance builds [2 sets in week 1, 3 sets in week 2, 4 sets in weeks 3+].<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pharyngeal constriction before intervention | 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention | Session 0 (Day 0 pre-intervention visit) | 
| Measurement of pharyngeal constriction after intervention | 2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention | Session 17 (9 week post-intervention visit) | 
| Measurement of pharyngeal shortening before intervention | 2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention | Session 0 (Day 0 pre-intervention visit) | 
| Measurement of pharyngeal shortening after intervention | 2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention | Session 17 (9 week post-intervention visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pharyngeal wall thickness before intervention | 2D lateral videofluoroscopic images will be used to measure wall thickness pre and post intervention | Session 0 (Day 0 pre-intervention visit) | 
| Measurement of pharyngeal wall thickness after intervention | 2D lateral videofluoroscopic images will be used to measure wall thickness pre and post intervention | Session 17 (9 week post-intervention visit) | 
| Measurement of pharyngeal volume before intervention | Acoustic Pharyngometry will be used to measure pharyngeal volume pre and post intervention. | Session 0 (Day 0 pre-intervention visit) | 
| Measurement of pharyngeal volume after intervention | Acoustic Pharyngometry will be used to measure pharyngeal volume pre and post intervention. | Session 17 (9 week post-intervention visit) |