Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises

Sponsor

NYU Langone Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05080725

Collaborator

(none)

Enrollment

Location

Arm

6.3

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia	Other: TelePEPP intervention	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises

Actual Study Start Date :

May 24, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Generalized sarcopenia group Twenty 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 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+].

Arm

Intervention/Treatment

Experimental: Generalized sarcopenia group

Twenty 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

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+].

Outcome Measures

Primary Outcome Measures

Measurement of pharyngeal constriction before intervention [Session 0 (Day 0 pre-intervention visit)]
2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Measurement of pharyngeal constriction after intervention [Session 17 (9 week post-intervention visit)]
2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Measurement of pharyngeal shortening before intervention [Session 0 (Day 0 pre-intervention visit)]
2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention
Measurement of pharyngeal shortening after intervention [Session 17 (9 week post-intervention visit)]
2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Sonja M Molfenter, PhD, CCC-SLP, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT05080725

Other Study ID Numbers:

19-00860

First Posted:

Oct 18, 2021

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Deglutition Disorders

Study Results

No Results Posted as of Aug 11, 2022