Clinical trial NCT05963113: Pharyngeal Exercise (Plus Protein)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Frail Older Adults
Keywords: proactive exercise
protein
nutrition
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Primary outcomes:
measure: Change in Thickness of the Superior Pharyngeal Constrictor Muscle
timeFrame: Baseline, Week 13
measure: Change in Thickness of the Superior Pharyngeal Constrictor Muscle
timeFrame: Baseline, Week 28
measure: Change in Thickness of the Middle Pharyngeal Constrictor Muscle
timeFrame: Baseline, Week 13
measure: Change in Thickness of the Middle Pharyngeal Constrictor Muscle
timeFrame: Baseline, Week 28
measure: Change in Thickness of the Inferior Pharyngeal Constrictor Muscle
timeFrame: Baseline, Week 13
measure: Change in Thickness of the Inferior Pharyngeal Constrictor Muscle
timeFrame: Baseline, Week 28
measure: Change in Maximum Pharyngeal Constriction During Swallowing
timeFrame: Baseline, Week 13
measure: Change in Maximum Pharyngeal Constriction During Swallowing
timeFrame: Baseline, Week 28
Secondary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) Scores
timeFrame: Baseline, Week 13
measure: Change in Short Physical Performance Battery (SPPB) Scores
timeFrame: Baseline, Week 28
measure: Change in Fat-Free Muscle Index
timeFrame: Baseline, Week 13
measure: Change in Fat-Free Muscle Index
timeFrame: Baseline, Week 28
measure: Change in Pre-Albumin Levels
timeFrame: Baseline, Week 13
measure: Change in Pre-Albumin Levels
timeFrame: Baseline, Week 28
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Steinhardt School of Education
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sonja Molfenter
role: PRINCIPAL_INVESTIGATOR
References: