Clinical trial NCT05080725: Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises
Official title: Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 2
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Measurement of pharyngeal constriction before intervention
timeFrame: Session 0 (Day 0 pre-intervention visit)
measure: Measurement of pharyngeal constriction after intervention
timeFrame: Session 17 (9 week post-intervention visit)
measure: Measurement of pharyngeal shortening before intervention
timeFrame: Session 0 (Day 0 pre-intervention visit)
measure: Measurement of pharyngeal shortening after intervention
timeFrame: Session 17 (9 week post-intervention visit)
Secondary outcomes:
measure: Measurement of pharyngeal wall thickness before intervention
timeFrame: Session 0 (Day 0 pre-intervention visit)
measure: Measurement of pharyngeal wall thickness after intervention
timeFrame: Session 17 (9 week post-intervention visit)
measure: Measurement of pharyngeal volume before intervention
timeFrame: Session 0 (Day 0 pre-intervention visit)
measure: Measurement of pharyngeal volume after intervention
timeFrame: Session 17 (9 week post-intervention visit)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sonja M Molfenter, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: