Pharyngeal Exercise (Plus Protein)

NCT05963113 | Recruiting DMC

• 1 other identifier: 23-00293
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Keywords

proactive exercise; protein; nutrition

Outcome Measures

Primary Outcomes (8)

• Change in Thickness of the Superior Pharyngeal Constrictor Muscle

  Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle.

  Baseline, Week 13

• Change in Thickness of the Superior Pharyngeal Constrictor Muscle

  Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle.

  Baseline, Week 28

• Change in Thickness of the Middle Pharyngeal Constrictor Muscle

  Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle.

  Baseline, Week 13

• Change in Thickness of the Middle Pharyngeal Constrictor Muscle

  Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle.

  Baseline, Week 28

• Change in Thickness of the Inferior Pharyngeal Constrictor Muscle

  Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle.

  Baseline, Week 13

• Change in Thickness of the Inferior Pharyngeal Constrictor Muscle

  Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle.

  Baseline, Week 28

• Change in Maximum Pharyngeal Constriction During Swallowing

  Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.

  Baseline, Week 13

• Change in Maximum Pharyngeal Constriction During Swallowing

  Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.

  Baseline, Week 28

Secondary Outcomes (6)

• Change in Short Physical Performance Battery (SPPB) Scores

  Baseline, Week 13

• Change in Short Physical Performance Battery (SPPB) Scores

  Baseline, Week 28

• Change in Fat-Free Muscle Index

  Baseline, Week 13

• Change in Fat-Free Muscle Index

  Baseline, Week 28

• Change in Pre-Albumin Levels

  Baseline, Week 13

Study Arms (2)

Control, then Swallowing Exercises + Protein

EXPERIMENTAL

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; Dietary Supplement: Protein Supplementation; Device: MRI

Control, then Swallowing Exercises

ACTIVE COMPARATOR

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; Device: MRI

Interventions

Pharyngeal Swallowing Exercises BEHAVIORAL

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.

Control, then Swallowing Exercises; Control, then Swallowing Exercises + Protein

Protein Supplementation DIETARY_SUPPLEMENT

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.

Control, then Swallowing Exercises + Protein

MRI DEVICE

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

Control, then Swallowing Exercises; Control, then Swallowing Exercises + Protein

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known structural or neurological causes of dysphagia.
• Cannot consume high levels of protein (Chronic Kidney Disease Stage 3 or higher).
• 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).

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

NYU Steinhardt School of Education

New York, New York, 10003, United States

RECRUITING

NYU Langone Health

New York, New York, 10017, United States

RECRUITING

Study Officials

• Sonja Molfenter

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja Molfenter

CONTACT

212-992-7694; Smm16@nyu.edu

Maria Travino Sampler

CONTACT

Maria.TrivinoSamper@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: May 22, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to smm16@nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)