Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      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: 
      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).
    

Intervention name(s): TelePEPP intervention
Intervention type(s): Other
Intervention description(s): 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+].
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment