Improving swallowing strength in older adults through exercise and protein
A Single-center Randomized Clinical Trial to Test the Efficacy of Pharyngeal Swallowing Exercises (With or Without Protein Supplementation) to Build Pharyngeal Muscular Reserve in Pre-frail Older Adults
This study tests if a 12-week program of swallowing exercises, with or without protein supplements, can help older adults aged 65 and up strengthen their swallowing muscles and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT05963113 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of a 12-week program of swallowing exercises, with or without daily protein supplements, aimed at enhancing the strength and function of swallowing muscles in pre-frail older adults. Participants, aged 65 and older, will engage in proactive exercises designed to improve muscle composition and overall health. Each participant will serve as their own control before being randomized to either the exercise-only group or the exercise plus protein group. The study will also explore the relationship between improved swallowing function and overall physical health.
Who should consider this trial
Good fit: Ideal candidates for this study are community-dwelling older adults aged 65 and above who exhibit signs of pre-frailty.
Not a fit: Patients with known structural or neurological causes of swallowing difficulties or those with chronic kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance swallowing function and nutritional status in older adults, potentially reducing frailty and improving quality of life.
How similar studies have performed: While the specific combination of swallowing exercises and protein supplementation is novel, similar studies have shown positive outcomes in improving muscle function and health in older adults.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
New York, New York and 1 other locations
- NYU Steinhardt School of Education — New York, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sonja Molfenter — NYU Langone Health
- Study coordinator: Sonja Molfenter
- Email: Smm16@nyu.edu
- Phone: 212-992-7694
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.