Improving swallowing strength in older adults through exercise and protein

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.