Pre-Frail Older Adults
Conditions
Keywords
proactive exercise, protein, nutrition
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.
Interventions
BEHAVIORALPharyngeal 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_SUPPLEMENTProtein 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.
DEVICEMRI
Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.
Sponsors
NYU Langone Health
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The PI, outcome assessors, and individuals conducting data analyses will be blinded to randomization. The treating clinicians and participants will be aware of their study group given that they will be provided with either water or protein drinks.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Thickness of the Superior Pharyngeal Constrictor Muscle | Baseline, Week 13 | 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 | Baseline, Week 13 | 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 | Baseline, Week 13 | 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 | Baseline, Week 13 | Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Scores | Baseline, Week 13 | The SPPB comprises a gait speed test, a chair stand test, and three balance tests. The gait speed test score ranges from 0 (worst outcome) to 4 (best outcome); the chair stand test score ranges from 0 (worst outcome) to 4 (best outcome); the side-by-side stand test score ranges from 1 (best outcome) to 0 (worst outcome); the semi-tandem stand test score ranges from 1 (best outcome) to 0 (worst outcome); and the tandem stand test scores range from 2 (best outcome) to 0 (worst outcome). The total SPPB score is the sum of the test scores and ranges from 0-12, with lower scores indicating greater disability. |
| Change in Fat-Free Muscle Index | Baseline, Week 13 | Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer. |
| Change in Pre-Albumin Levels | Baseline, Week 13 | Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples. |
Countries
United States
Contacts
CONTACTSonja Molfenter
CONTACTMaria Travino Sampler
PRINCIPAL_INVESTIGATORSonja Molfenter
NYU Langone Health
Outcome results
None listed