Pre-Frail Older AdultsPE(PP)NCT05963113
Pharyngeal Exercise (Plus Protein)
A study testing Pharyngeal Swallowing Exercises, Protein Supplementation and MRI in people with Pre-Frail Older Adults, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-Frail Older Adults
- What is being tested?
- Pharyngeal Swallowing Exercises, Protein Supplementation and MRI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Travino Sampler contact
United States2 sites, 2 recruiting
- Recruiting
NYU Steinhardt School of Education
New York, New York, 10003
- Recruiting
NYU Langone Health
New York, New York, 10017
About this study
Official title: 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
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.
- Conditions
- Pre-Frail Older Adults
- Being tested
- Pharyngeal Swallowing Exercises, Protein Supplementation, MRI
- Keywords
- proactive exercise, protein, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal Swallowing ExercisesBehavioural
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 SupplementationDietary 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.
MRIDevice
Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: Behavioral: Pharyngeal Swallowing Exercises; Dietary Supplement: Protein Supplementation; Device: MRI |
| 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." Receives: Behavioral: Pharyngeal Swallowing Exercises; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 28
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 28
Change in Pre-Albumin Levels
Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.
Measured: Baseline, Week 13
Change in Pre-Albumin Levels
Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples.
Measured: Baseline, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start22 May 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Frail Older AdultsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sonja Molfenter, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963113
- Sponsor's protocol ID
- 23-00293
- Acronym
- PE(PP)
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05963113
- Acronym / sponsor ID
- PE(PP) / 23-00293
- Conditions
- Pre-Frail Older Adults
- Keywords
- proactive exercise, protein, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 May 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control, then Swallowing Exercises + Protein | Experimental | Behavioral: Pharyngeal Swallowing Exercises, Dietary Supplement: Protein Supplementation, Device: MRIParticipants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity." |
| Control, then Swallowing Exercises | Active comparator | Behavioral: Pharyngeal Swallowing Exercises, Device: MRIParticipants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity." |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharyngeal Swallowing Exercises12-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. | Behavioural | Control, then Swallowing Exercises, Control, then Swallowing Exercises + Protein |
| Protein Supplementation12-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. | Dietary supplement | Control, then Swallowing Exercises + Protein |
| MRIParticipants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil. | Device | Control, then Swallowing Exercises, Control, then Swallowing Exercises + Protein |
Primary outcome
Change in 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 superior pharyngeal constrictor muscle.
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 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 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 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 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 13
Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.
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.
6 secondary outcomes
Change in Short Physical Performance Battery (SPPB) Scores
Time frame: Baseline, Week 13
Change in Short Physical Performance Battery (SPPB) Scores
Time frame: Baseline, Week 28
Change in Fat-Free Muscle Index
Time frame: Baseline, Week 13
Change in Fat-Free Muscle Index
Time frame: Baseline, Week 28
Change in Pre-Albumin Levels
Time frame: Baseline, Week 13
Change in Pre-Albumin Levels
Time frame: Baseline, Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Travino Sampler contact
Sonja Molfenter principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal Swallowing Exercises, Protein Supplementation and MRI in people with Pre-Frail Older Adults, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonja Molfenter (212-992-7694, Smm16@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Thickness of the Superior Pharyngeal Constrictor Muscle (time frame: Baseline, Week 13). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.