Recruiting

Pharyngeal Exercise with Protein

Sponsor:

NYU Langone Health

Code:

NCT05963113

Conditions

Pre-Frail Older Adults

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Pharyngeal Swallowing Exercises

Protein Supplementation

MRI

Study Details

Brief 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.

Conditions

Pre-Frail Older Adults

Study ID

NCT05963113

Start date

May 22, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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."

Interventions

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.

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.

MRI

Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.

Primary outcome measure

  • Change in Thickness of the Superior Pharyngeal Constrictor Muscle [ Time Frame: Baseline, Week 13 ]
  • Change in Thickness of the Superior Pharyngeal Constrictor Muscle [ Time Frame: Baseline, Week 28 ]
  • Change in Thickness of the Middle Pharyngeal Constrictor Muscle [ Time Frame: Baseline, Week 13 ]
  • Change in Thickness of the Middle Pharyngeal Constrictor Muscle [ Time Frame: Baseline, Week 28 ]
  • Change in Thickness of the Inferior Pharyngeal Constrictor Muscle [ Time Frame: Baseline, Week 13 ]
  • Change in Thickness of the Inferior Pharyngeal Constrictor Muscle [ Time Frame: Baseline, Week 28 ]
  • Change in Maximum Pharyngeal Constriction During Swallowing [ Time Frame: Baseline, Week 13 ]
  • Change in Maximum Pharyngeal Constriction During Swallowing [ Time Frame: Baseline, Week 28 ]

Central Contacts and Locations

Central contacts

Sonja Molfenter

212-992-7694Smm16@nyu.edu

Maria Travino Sampler

Maria.TrivinoSamper@nyulangone.org

Locations

NYU Steinhardt School of Education

Recruiting

New York, New York, United States, 10003

NYU Langone Health

Recruiting

New York, New York, United States, 10017

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • proactive exercise
  • protein
  • nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-03.