Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
NCT05963113

Pharyngeal Exercise (Plus Protein)

Led by NYU Langone Health · Updated on 2025-08-05

120

Participants Needed

2

Research Sites

240 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The swallowing muscles are prone to decreased strength and function as part of the natural aging process which can lead to difficulty swallowing, malnutrition, and frailty. Exercise and nutrition are powerful stimulators of muscular change. The proposed research will investigate the effectiveness of a 12-week proactive regimen of swallowing exercises (with or without daily protein supplement drinks) to improve the composition, force, and physiology of the swallowing muscles and explore the relationship to overall health and physical function in 80 community-dwelling older adults. Each participant will serve as their own control for 12 weeks before being randomized to complete swallowing exercises alone or swallowing exercises with protein drinks.

CONDITIONS

Official Title

Pharyngeal Exercise (Plus Protein)

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 65 years of age or older
  • Participants must score a 1 or 2 on the FRAIL scale or 4 or greater on the SARC-F Questionnaire
  • Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA)
  • Willingness to participate in the study procedures
Not Eligible

You will not qualify if you...

  • Known structural or neurological causes of dysphagia
  • Unable to consume high levels of protein due to Chronic Kidney Disease Stage 3 or higher
  • Contraindications to 3T whole body MRI scanners such as pacemaker, cerebral aneurysm clip, cochlear implant, shrapnel in critical areas, metal in the eye, or claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

NYU Steinhardt School of Education

New York, New York, United States, 10003

Actively Recruiting

2

NYU Langone Health

New York, New York, United States, 10017

Actively Recruiting

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Research Team

S

Sonja Molfenter

CONTACT

M

Maria Travino Sampler

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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