Pharyngeal Exercise (Plus Protein)

Not Applicable

Recruiting

• Conditions: Pre-Frail Older Adults
• Interventions: Behavioral: Pharyngeal Swallowing Exercises; Dietary Supplement: Protein Supplementation; Device: MRI

• Registration Number: NCT05963113
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-27
• Study Start: 2024-05-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Primary Completion: 2028-08-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control, then Swallowing Exercises + Protein	Pharyngeal Swallowing Exercises	Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
Control, then Swallowing Exercises + Protein	Protein Supplementation	Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
Control, then Swallowing Exercises + Protein	MRI	Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
Control, then Swallowing Exercises	Pharyngeal Swallowing Exercises	Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."
Control, then Swallowing Exercises	MRI	Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."

Primary Outcome Measures

Name	Time	Method
Change in Thickness of the Superior Pharyngeal Constrictor Muscle	Baseline, Week 28	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.
Change in Thickness of the Middle Pharyngeal Constrictor Muscle	Baseline, Week 28	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.
Change in Thickness of the Inferior Pharyngeal Constrictor Muscle	Baseline, Week 28	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.
Change in Maximum Pharyngeal Constriction During Swallowing	Baseline, Week 28	Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.

Secondary Outcome Measures

Name	Time	Method
Change in Short Physical Performance Battery (SPPB) Scores	Baseline, Week 28	The SPPB comprises a gait speed test, a chair stand test, and three balance tests. The gait speed test score ranges from 0 (worst outcome) to 4 (best outcome); the chair stand test score ranges from 0 (worst outcome) to 4 (best outcome); the side-by-side stand test score ranges from 1 (best outcome) to 0 (worst outcome); the semi-tandem stand test score ranges from 1 (best outcome) to 0 (worst outcome); and the tandem stand test scores range from 2 (best outcome) to 0 (worst outcome).; The total SPPB score is the sum of the test scores and ranges from 0-12, with lower scores indicating greater disability.
Change in Fat-Free Muscle Index	Baseline, Week 28	Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer.
Change in Pre-Albumin Levels	Baseline, Week 28	Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.

Trial Locations

Locations (2)

NYU Langone Health; 🇺🇸 New York, New York, United States

NYU Steinhardt School of Education; 🇺🇸 New York, New York, United States