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Pharyngeal Exercise (Plus Protein)

Purpose

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.

Condition

Pre-Frail Older Adults

Eligibility

Eligible Ages: Over 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

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

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).

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The PI, outcome assessors, and individuals conducting data analyses will be blinded to randomization. The treating clinicians and participants will be aware of their study group given that they will be provided with either water or protein drinks.

Arm Groups

Arm	Description	Assigned Intervention
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."	Behavioral: Pharyngeal Swallowing Exercises 12-weeks of proactive pharyngeal swallowing exercises conducted 5 times per week. The exercise program will include the following four exercises: effortful saliva swallows, tongue-hold swallows, effortful pitch glides and posterior lingual resistance. Each exercise set will include 10 repetitions of each exercise (40 reps per set). The number of sets will be gradually increased as tolerance builds. Dietary Supplement: Protein Supplementation 12-week supply of the commercially-available Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink). Participants will be asked to consume one drink per day for the 12-week intervention period. Device: MRI Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.
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."	Behavioral: Pharyngeal Swallowing Exercises 12-weeks of proactive pharyngeal swallowing exercises conducted 5 times per week. The exercise program will include the following four exercises: effortful saliva swallows, tongue-hold swallows, effortful pitch glides and posterior lingual resistance. Each exercise set will include 10 repetitions of each exercise (40 reps per set). The number of sets will be gradually increased as tolerance builds. Dietary Supplement: Protein Supplementation 12-week supply of the commercially-available Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink). Participants will be asked to consume one drink per day for the 12-week intervention period. Device: MRI Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.

Recruiting Locations

NYU Steinhardt School of Education
New York, New York 10003

NYU Langone Health
New York, New York 10017

More Details

NCT ID: NCT05963113
Status: Recruiting
Sponsor: NYU Langone Health

Study Contact

Sonja Molfenter
212-992-7694
Smm16@nyu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.