DysphagiaNCT05080725
Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises
A study testing TelePEPP intervention in people with Dysphagia, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how exercise and protein supply affect swallow muscles. Twenty healthy older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- TelePEPP intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 4 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 and older
- SARC-F score of ≥4
- Functional hearing and vision status
- Access to reliable internet connection
- Availability of caregiver/family support and/or comfort with independent technology usage
Who cannot join
- Known structural or neurological causes of dysphagia
- Not suitable to consume high levels of protein supplementation (i.e. moderate to severe kidney dysfunction)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to learn more about how exercise and protein supply affect swallow muscles. Twenty healthy older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Zoom. During each session, a series of swallow exercises will be performed following a demonstration from a trained speech-language pathologist. Participants will be referred to NYU Langone Health or White Plains Hospital, for a videofluoroscopic swallowing study, acoustic pharyngometry and measures of hand grip strength before and after the treatment protocol. Patients will be able to select their preferred site for swallow study completion. Results will inform the relationship between swallow exercises and pharyngeal muscles. All devices and exercises are established as safe and effective and are FDA approved.
Read the detailed description
The natural next step in this program of research is to investigate interventions for reversing pharyngeal sarcopenia with the ultimate goal of developing novel therapeutic strategies to address this pervasive clinical issue. The exercise science literature suggests that sarcopenia in the limb muscles can be reversed through a combination of rigorous exercise and adequate levels of dietary protein. The innovative multi-disciplinary protocol, PEPP (Pharyngeal Exercises Plus Protein), combines pharyngeal swallowing exercises selected for their known activation of the pharyngeal muscles with daily supplemental protein drinks. The research lab had documented successful improvements to swallowing physiology and pharyngeal sarcopenia in a pilot series of 5 older women using PEPP. However the research was abruptly halted due to both ethical and feasibility challenges posed by the COVID-19 pandemic. In response to these challenges, this study is seeking to establish the feasibility and effectiveness when the PEPP intervention is delivered using telehealth (telePEPP).
- Conditions
- Dysphagia
- Being tested
- TelePEPP intervention
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelePEPP interventionOther
TelePEPP sessions will be conducted twice per week by a Speech Language Pathologist and/or graduate student clinician, on the study team. This clinician will deliver the intervention from the NYU Voice Center using the web conferencing software Webex (institutional license) on a Dell desktop computer with a 3.1 GHz intel core processor and high definition camera. Each exercise set will include 40 repetitions (10 reps of effortful swallows, tongue hold swallows, effortful pitch glides and maximal posterior tongue presses). All exercises are widely-adopted by clinicians as standard of care exercises. The number of sets will be gradually increased as tolerance builds [2 sets in week 1, 3 sets in week 2, 4 sets in weeks 3+].
| Study group | Role | What they receive |
|---|---|---|
| Generalized sarcopenia group | Experimental | Older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Webex. During each session, a series of standard of care swallow exercises will be performed following a demonstration from a trained speech-language pathologist. Receives: Other: TelePEPP intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pharyngeal constriction before intervention
2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Measured: Session 0 (Day 0 pre-intervention visit)
Measurement of pharyngeal constriction after intervention
2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Measured: Session 17 (9 week post-intervention visit)
Measurement of pharyngeal shortening before intervention
2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention
Measured: Session 0 (Day 0 pre-intervention visit)
Measurement of pharyngeal shortening after intervention
2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention
Measured: Session 17 (9 week post-intervention visit)
Secondary outcomes (4)
Measurement of pharyngeal wall thickness before intervention
2D lateral videofluoroscopic images will be used to measure wall thickness pre and post intervention
Measured: Session 0 (Day 0 pre-intervention visit)
Measurement of pharyngeal wall thickness after intervention
2D lateral videofluoroscopic images will be used to measure wall thickness pre and post intervention
Measured: Session 17 (9 week post-intervention visit)
Measurement of pharyngeal volume before intervention
Acoustic Pharyngometry will be used to measure pharyngeal volume pre and post intervention.
Measured: Session 0 (Day 0 pre-intervention visit)
Measurement of pharyngeal volume after intervention
Acoustic Pharyngometry will be used to measure pharyngeal volume pre and post intervention.
Measured: Session 17 (9 week post-intervention visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start24 May 2022
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonja M Molfenter, PhD, CCC-SLP, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080725
- Sponsor's protocol ID
- 19-00860
- Status last verified
- Feb 2023
- First submitted
- 9 Sep 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is to collect a series of pilot data to support an NIH grant submission to test the intervention during a randomized control trial. If the application is successful, the IPD of the NIH funded RCT will be made sharable.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises
- ClinicalTrials.gov ID
- NCT05080725
- Acronym / sponsor ID
- 19-00860
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 18 Oct 2021 (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 purpose of this study is to learn more about how exercise and protein supply affect swallow muscles. Twenty healthy older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Zoom. During each session, a series of swallow exercises will be performed following a demonstration from a trained speech-language pathologist. Participants will be referred to NYU Langone Health or White Plains Hospital, for a videofluoroscopic swallowing study, acoustic pharyngometry and measures of hand grip strength before and after the treatment protocol. Patients will be able to select their preferred site for swallow study completion. Results will inform the relationship between swallow exercises and pharyngeal muscles. All devices and exercises are established as safe and effective and are FDA approved.
Detailed description
The natural next step in this program of research is to investigate interventions for reversing pharyngeal sarcopenia with the ultimate goal of developing novel therapeutic strategies to address this pervasive clinical issue. The exercise science literature suggests that sarcopenia in the limb muscles can be reversed through a combination of rigorous exercise and adequate levels of dietary protein. The innovative multi-disciplinary protocol, PEPP (Pharyngeal Exercises Plus Protein), combines pharyngeal swallowing exercises selected for their known activation of the pharyngeal muscles with daily supplemental protein drinks. The research lab had documented successful improvements to swallowing physiology and pharyngeal sarcopenia in a pilot series of 5 older women using PEPP. However the research was abruptly halted due to both ethical and feasibility challenges posed by the COVID-19 pandemic. In response to these challenges, this study is seeking to establish the feasibility and effectiveness when the PEPP intervention is delivered using telehealth (telePEPP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Generalized sarcopenia group | Experimental | Other: TelePEPP interventionOlder adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Webex. During each session, a series of standard of care swallow exercises will be performed following a demonstration from a trained speech-language pathologist. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 and older
- SARC-F score of ≥4
- Functional hearing and vision status
- Access to reliable internet connection
- Availability of caregiver/family support and/or comfort with independent technology usage
Key exclusion criteria (2 listed)
- Known structural or neurological causes of dysphagia
- Not suitable to consume high levels of protein supplementation (i.e. moderate to severe kidney dysfunction)
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 |
|---|---|---|
| TelePEPP interventionTelePEPP sessions will be conducted twice per week by a Speech Language Pathologist and/or graduate student clinician, on the study team. This clinician will deliver the intervention from the NYU Voice Center using the web conferencing software Webex (institutional license) on a Dell desktop computer with a 3.1 GHz intel core processor and high definition camera. Each exercise set will include 40 repetitions (10 reps of effortful swallows, tongue hold swallows, effortful pitch glides and maximal posterior tongue presses). All exercises are widely-adopted by clinicians as standard of care exercises. The number of sets will be gradually increased as tolerance builds [2 sets in week 1, 3 sets in week 2, 4 sets in weeks 3+]. | Other | Generalized sarcopenia group |
Primary outcome
Measurement of pharyngeal constriction before intervention
Time frame: Session 0 (Day 0 pre-intervention visit)
2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Measurement of pharyngeal constriction after intervention
Time frame: Session 17 (9 week post-intervention visit)
2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Measurement of pharyngeal shortening before intervention
Time frame: Session 0 (Day 0 pre-intervention visit)
2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention
Measurement of pharyngeal shortening after intervention
Time frame: Session 17 (9 week post-intervention visit)
2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention
4 secondary outcomes
Measurement of pharyngeal wall thickness before intervention
Time frame: Session 0 (Day 0 pre-intervention visit)
Measurement of pharyngeal wall thickness after intervention
Time frame: Session 17 (9 week post-intervention visit)
Measurement of pharyngeal volume before intervention
Time frame: Session 0 (Day 0 pre-intervention visit)
Measurement of pharyngeal volume after intervention
Time frame: Session 17 (9 week post-intervention visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No. This study is to collect a series of pilot data to support an NIH grant submission to test the intervention during a randomized control trial. If the application is successful, the IPD of the NIH funded RCT will be made sharable.
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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. This study is not recruiting at the moment.
Sonja M Molfenter, PhD, CCC-SLP principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TelePEPP intervention in people with Dysphagia, run by NYU Langone Health at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pharyngeal constriction before intervention (time frame: Session 0 (Day 0 pre-intervention visit)). The study lists 4 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 24 Feb 2023.