Skip to main content
OpenTrials
Completed

NCT Number: NCT05080725

Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TelePEPP intervention

Other

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+].

Primary outcomes

  1. Measurement of pharyngeal constriction before intervention

    Time frame: Session 0 (Day 0 pre-intervention visit)

    2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention

  2. Measurement of pharyngeal constriction after intervention

    Time frame: Session 17 (9 week post-intervention visit)

    2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention

  3. Measurement of pharyngeal shortening before intervention

    Time frame: Session 0 (Day 0 pre-intervention visit)

    2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention

  4. Measurement of pharyngeal shortening after intervention

    Time frame: Session 17 (9 week post-intervention visit)

    2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention

Secondary outcomes

  1. Measurement of pharyngeal wall thickness before intervention

    Time frame: Session 0 (Day 0 pre-intervention visit)

    2D lateral videofluoroscopic images will be used to measure wall thickness pre and post intervention

  2. Measurement of pharyngeal wall thickness after intervention

    Time frame: Session 17 (9 week post-intervention visit)

    2D lateral videofluoroscopic images will be used to measure wall thickness pre and post intervention

  3. Measurement of pharyngeal volume before intervention

    Time frame: Session 0 (Day 0 pre-intervention visit)

    Acoustic Pharyngometry will be used to measure pharyngeal volume pre and post intervention.

  4. Measurement of pharyngeal volume after intervention

    Time frame: Session 17 (9 week post-intervention visit)

    Acoustic Pharyngometry will be used to measure pharyngeal volume pre and post intervention.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2021
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.