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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-Frail Older Adults
- Sponsor
- NYU Langone Health
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Change in Thickness of the Superior Pharyngeal Constrictor Muscle
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
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).
Outcomes
Primary Outcomes
Change in Thickness of the Superior Pharyngeal Constrictor Muscle
Time Frame: Baseline, Week 28
Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle.
Change in Thickness of the Middle Pharyngeal Constrictor Muscle
Time Frame: Baseline, Week 28
Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle.
Change in Thickness of the Inferior Pharyngeal Constrictor Muscle
Time Frame: Baseline, Week 28
Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle.
Change in Maximum Pharyngeal Constriction During Swallowing
Time Frame: Baseline, Week 28
Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.
Secondary Outcomes
- Change in Short Physical Performance Battery (SPPB) Scores(Baseline, Week 28)
- Change in Fat-Free Muscle Index(Baseline, Week 28)
- Change in Pre-Albumin Levels(Baseline, Week 28)