RECRUITING

Pharyngeal Exercise (Plus Protein)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-22
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05963113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants must be 65 years of age or older.
  2. 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. 3. Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA).
  4. 4. Willingness to participate in the study procedures.
  1. 1. Known structural or neurological causes of dysphagia.
  2. 2. Cannot consume high levels of protein (Chronic Kidney Disease Stage 3 or higher).
  3. 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).

Contacts and Locations

Study Contact

Sonja Molfenter
CONTACT
212-992-7694
Smm16@nyu.edu
Claire Crossman
CONTACT
Claire.Crossman@nyulangone.org

Principal Investigator

Sonja Molfenter
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Steinhardt School of Education
New York, New York, 10003
United States
NYU Langone Health
New York, New York, 10017
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Sonja Molfenter, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-22
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-05-22
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • proactive exercise
  • protein
  • nutrition

Additional Relevant MeSH Terms

  • Pre-Frail Older Adults