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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control, then Swallowing Exercises + Protein | Experimental | Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity." |
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| Control, then Swallowing Exercises | Active Comparator | Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity." |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Thickness of the Superior Pharyngeal Constrictor Muscle | 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. | Baseline, Week 13 |
| Change in Thickness of the Superior Pharyngeal Constrictor Muscle | 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. | Baseline, Week 28 |
| Change in Thickness of the Middle Pharyngeal Constrictor Muscle | 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. | Baseline, Week 13 |
| Change in Thickness of the Middle Pharyngeal Constrictor Muscle | 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. | Baseline, Week 28 |
| Change in Thickness of the Inferior Pharyngeal Constrictor Muscle | 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. | Baseline, Week 13 |
| Change in Thickness of the Inferior Pharyngeal Constrictor Muscle | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Scores | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Molfenter | Contact | 212-992-7694 | Smm16@nyu.edu | |
| Maria Travino Sampler | Contact | Maria.TrivinoSamper@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Sonja Molfenter | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Steinhardt School of Education | Recruiting | New York | New York | 10003 | United States | |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: smm16@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to smm16@nyu.edu. To gain access, data requestors will need to sign a data access agreement.
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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.
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| 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. |
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| MRI | Device | Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil. |
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| Baseline, Week 28 |
| Change in Maximum Pharyngeal Constriction During Swallowing | Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy. | Baseline, Week 13 |
| Change in Maximum Pharyngeal Constriction During Swallowing | Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy. | Baseline, Week 28 |
| Baseline, Week 13 |
| Change in Short Physical Performance Battery (SPPB) Scores | 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. | Baseline, Week 28 |
| Change in Fat-Free Muscle Index | Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer. | Baseline, Week 13 |
| Change in Fat-Free Muscle Index | Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer. | Baseline, Week 28 |
| Change in Pre-Albumin Levels | Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples. | Baseline, Week 13 |
| Change in Pre-Albumin Levels | Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples. | Baseline, Week 28 |
| NYU Langone Health |
| Recruiting |
| New York |
| New York |
| 10017 |
| United States |