Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises

NCT05080725 | Completed DMC

• 1 other identifier: 19-00860
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (4)

• Measurement of pharyngeal constriction before intervention

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

  Session 0 (Day 0 pre-intervention visit)

• Measurement of pharyngeal constriction after intervention

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

  Session 17 (9 week post-intervention visit)

• Measurement of pharyngeal shortening before intervention

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

  Session 0 (Day 0 pre-intervention visit)

• Measurement of pharyngeal shortening after intervention

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

  Session 17 (9 week post-intervention visit)

Secondary Outcomes (4)

• Measurement of pharyngeal wall thickness before intervention

  Session 0 (Day 0 pre-intervention visit)

• Measurement of pharyngeal wall thickness after intervention

  Session 17 (9 week post-intervention visit)

• Measurement of pharyngeal volume before intervention

  Session 0 (Day 0 pre-intervention visit)

• Measurement of pharyngeal volume after intervention

  Session 17 (9 week post-intervention visit)

Study Arms (1)

Generalized sarcopenia group

EXPERIMENTAL

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

Interventions

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 \[2 sets in week 1, 3 sets in week 2, 4 sets in weeks 3+\].

Generalized sarcopenia group

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known structural or neurological causes of dysphagia
• Not suitable to consume high levels of protein supplementation (i.e. moderate to severe kidney dysfunction)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sonja M Molfenter, PhD, CCC-SLP

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 18, 2021
• Study Start: May 24, 2022
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)