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Recruiting NCT05963113

Pharyngeal Exercise (Plus Protein)

No phase Interventional Pre-Frail Older Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharyngeal Swallowing Exercises, Protein Supplementation, MRI.
Who it may be relevant to
Registry conditions: Pre-Frail Older Adults. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Behavioral Pharyngeal Swallowing Exercises
    12-weeks of proactive pharyngeal swallowing exercises conducted 5 times per week. The exercise program will include the following four exercises: effortful saliva swallows, tongue-hold swallows, effortful pitch glides and posterior lingual resistance. Each exercise set will include 10 repetitions of each exercise (40 reps per set). The number of sets will be gradually increased as tolerance builds.
  • Dietary supplement Protein Supplementation
    12-week supply of the commercially-available Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink). Participants will be asked to consume one drink per day for the 12-week intervention period.
  • Device MRI
    Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.

Primary outcome measures

  • Change in Thickness of the Superior Pharyngeal Constrictor Muscle [Time frame: Baseline, Week 13]
  • Change in Thickness of the Superior Pharyngeal Constrictor Muscle [Time frame: Baseline, Week 28]
  • Change in Thickness of the Middle Pharyngeal Constrictor Muscle [Time frame: Baseline, Week 13]
  • Change in Thickness of the Middle Pharyngeal Constrictor Muscle [Time frame: Baseline, Week 28]
  • Change in Thickness of the Inferior Pharyngeal Constrictor Muscle [Time frame: Baseline, Week 13]
  • Change in Thickness of the Inferior Pharyngeal Constrictor Muscle [Time frame: Baseline, Week 28]
  • Change in Maximum Pharyngeal Constriction During Swallowing [Time frame: Baseline, Week 13]
  • Change in Maximum Pharyngeal Constriction During Swallowing [Time frame: Baseline, Week 28]
Secondary outcome measures (6)
  • Change in Short Physical Performance Battery (SPPB) Scores [Time frame: Baseline, Week 13]
  • Change in Short Physical Performance Battery (SPPB) Scores [Time frame: Baseline, Week 28]
  • Change in Fat-Free Muscle Index [Time frame: Baseline, Week 13]
  • Change in Fat-Free Muscle Index [Time frame: Baseline, Week 28]
  • Change in Pre-Albumin Levels [Time frame: Baseline, Week 13]
  • Change in Pre-Albumin Levels [Time frame: Baseline, Week 28]

Eligibility criteria

Inclusion criteria

  • Participants must be 65 years of age or older.
  • 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.
  • Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA).
  • Willingness to participate in the study procedures.

Exclusion criteria

  • Known structural or neurological causes of dysphagia.
  • Cannot consume high levels of protein (Chronic Kidney Disease Stage 3 or higher).
  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • NYU Steinhardt School of Education — New York
  • NYU Langone Health — New York

Identifiers

NCT: NCT05963113 · 23-00293

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗