| NCT ID | NCT05963113 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Pre-Frail Older Adults |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-05-22 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Sonja Molfenter
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05963113 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Pre-Frail Older Adults. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05963113 currently recruiting?
Yes, NCT05963113 is actively recruiting participants. Contact the research team at Smm16@nyu.edu for enrollment information.
Where is the NCT05963113 trial being conducted?
This trial is being conducted at New York, United States, New York, United States.
Who is sponsoring the NCT05963113 clinical trial?
NCT05963113 is sponsored by NYU Langone Health. The principal investigator is Sonja Molfenter at NYU Langone Health. The trial plans to enroll 120 participants.