Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises

NYU Langone Health

Status: Completed

Conditions: Dysphagia

Treatments: Other: TelePEPP intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05080725

19-00860

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2 patients

Sex: All

Ages: 65 to 120 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Generalized sarcopenia group

Experimental group

Description:

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.

Treatment:

Other: TelePEPP intervention