NCT Number: NCT05963113
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
NYU Langone Health, New York, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: Baseline, Week 13
Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.
Time frame: Baseline, Week 28
Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.
Time frame: 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.
Time frame: Baseline, Week 28
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.
Time frame: Baseline, Week 13
Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer.
Time frame: Baseline, Week 28
Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer.
Time frame: Baseline, Week 13
Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.
Time frame: Baseline, Week 28
Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.
Contact information is provided by the study sponsor or research team.
Maria Travino Sampler
CONTACT
Sonja Molfenter
CONTACT
NYU Langone Health
Other
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
Acronym: PE(PP)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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