A Single-center Randomized Clinical Trial to Test the Efficacy of Pharyngeal Swallowing Exercises (With or Without Protein Supplementation) to Build Pharyngeal Muscular Reserve in Pre-frail Older Adults

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement, Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• Participants must be 65 years of age or older.

• Participants must score a 1 or 2 on the FRAIL scale OR a 4 or greater on the Strength, Assistance in Walking, Rise from a Chair, Climb Stairs and Falls (SARC-F) Questionnaire.

• Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA).

• Willingness to participate in the study procedures.

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
NYU Steinhardt School of Education
RECRUITING
New York
Contact Information
Primary
Sonja Molfenter
Smm16@nyu.edu
212-992-7694
Backup
Maria Travino Sampler
Maria.TrivinoSamper@nyulangone.org
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Control, then Swallowing Exercises + Protein
Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of usual activity.
Active_comparator: Control, then Swallowing Exercises
Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of usual activity.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov