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Behavioral Intervention
Swallowing Exercises + Protein for Older Adults (PE(PP) Trial)
N/A
Recruiting
Led By Sonja Molfenter
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 28
Awards & highlights
PE(PP) Trial Summary
This trial will study the effects of swallowing exercises and protein drinks on elderly people's swallowing muscles and overall health.
Who is the study for?
This trial is for older adults who have some level of frailty or difficulty with physical activities like walking, standing up from a chair, climbing stairs, or are at risk of falls. They must be 65 years or older and mentally sharp enough to follow the study's procedures (scored by MoCA). People with swallowing issues due to structural/neurological reasons, severe kidney disease, or those unable to undergo MRI scans cannot participate.Check my eligibility
What is being tested?
The study tests if doing swallowing exercises for 12 weeks can strengthen the muscles involved in swallowing among seniors. It also looks at whether adding daily protein drinks enhances these benefits. Participants will first observe their normal routine without interventions and then be randomly assigned to either just do exercises or do them along with taking protein supplements.See study design
What are the potential side effects?
Potential side effects may include discomfort from performing the exercises and possible digestive changes due to increased protein intake. The MRI procedure might cause claustrophobia but is generally safe; however, it's not suitable for individuals with certain metal implants.
PE(PP) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Maximum Pharyngeal Constriction During Swallowing
Change in Thickness of the Inferior Pharyngeal Constrictor Muscle
Change in Thickness of the Middle Pharyngeal Constrictor Muscle
+1 moreSecondary outcome measures
Change in Fat-Free Muscle Index
Change in Pre-Albumin Levels
Change in Short Physical Performance Battery (SPPB) Scores
PE(PP) Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Control, then Swallowing Exercises + ProteinExperimental Treatment3 Interventions
Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
Group II: Control, then Swallowing ExercisesActive Control2 Interventions
Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Protein Supplementation
2019
N/A
~160
MRI
2009
Completed Phase 2
~1370
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,805 Total Patients Enrolled
8 Trials studying Older Adults
962 Patients Enrolled for Older Adults
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,518 Total Patients Enrolled
Sonja MolfenterPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.I am either somewhat frail or need help with physical activities.I cannot eat a lot of protein due to advanced kidney disease.I have a physical or nerve problem causing difficulty swallowing.
Research Study Groups:
This trial has the following groups:- Group 1: Control, then Swallowing Exercises
- Group 2: Control, then Swallowing Exercises + Protein
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for participation in this scientific experiment?
"The clinical trial's entry on the medical registry, clinicaltrials.gov, states that recruitment is not active at this time. Initially posted in September 1st of 2023 and last updated July 19th of the same year, it no longer accepting applicants; however there are still other trials seeking participants."
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