Pharyngeal Exercise (Plus Protein) (PE(PP))

NYU Langone Health

Status: Enrolling

Conditions: Pre-Frail Older Adults

Treatments: Device: MRI; Dietary Supplement: Protein Supplementation; Behavioral: Pharyngeal Swallowing Exercises

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05963113

23-00293

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants must be 65 years of age or older.
2. 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.
3. Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA).
4. Willingness to participate in the study procedures.

Exclusion criteria

1. Known structural or neurological causes of dysphagia.
2. Cannot consume high levels of protein (Chronic Kidney Disease Stage 3 or higher).
3. Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Control, then Swallowing Exercises + Protein

Experimental group

Description:

Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."

Treatment:

Behavioral: Pharyngeal Swallowing Exercises

Dietary Supplement: Protein Supplementation

Device: MRI

Control, then Swallowing Exercises

Active Comparator group

Description:

Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."

Treatment:

Behavioral: Pharyngeal Swallowing Exercises

Device: MRI