Pharyngeal Exercise (Plus Protein)

Conditions

• Pre-Frail Older Adults

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Pharyngeal Swallowing Exercises — BEHAVIORAL
  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.
• Protein Supplementation — DIETARY_SUPPLEMENT
  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.
• MRI — DEVICE
  Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.

Study Details

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.

Key Dates

Start date

May 22, 2024

Status verified

Jun 2026

Primary completion

Aug 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Control, then Swallowing Exercises + Protein
  Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
• Active Comparator: Control, then Swallowing Exercises
  Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."

Primary Outcome Measure

Change in Thickness of the Superior Pharyngeal Constrictor Muscle [ Time Frame: Baseline, Week 13 ]

Central Contacts

• Sonja Molfenter
  212-992-7694
  [email protected]
• Maria Travino Sampler
  [email protected]

Locations (2)

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