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DysphagiaNCT04975815

Frailty and Dysphagia in Older Adults

An observational study of Dysphagia and Frailty, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to figure out if there are physical factors such as cognition level, nutrition status, walking speed, and handgrip strength that are associated with the development of swallowing problems. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Dysphagia, Frailty
How many people
52 participants
Where
1 siteUnited States
Study dates
6 Apr 2022to 14 Mar 2025
Phase
Observational
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: 69 community-dwelling older adults (23 non-frail, 23 pre-frail, 23 frail) will be recruited from the UW Health Geriatrics clinics, Oakwood Village, a continuing care community for older adults located in Madison, WI, Pleasant View Nursing Home in Monroe, WI, and Skaalen Retirement Services in Stoughton, WI. Participants will attend two research visits. During the first study visit, a comprehensive assessment of limb function, gait, cognitive, and nutrition will be performed. Findings from this first session will allow us to calculate a Fried Frailty Index19 score for each participant and confirm their frailty status (non-frail, pre-frail, frail). During the second research visit, comprehensive swallowing assessments and saliva sample collection will occur. Given this is a cross-sectional study, enrollment will continue until the target of 69 participants (23 per group) is met.

Who may be able to join

  • 65 years of age or older
  • Ability to provide informed consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
  • Post-menopausal (female participants)
  • Not pregnant

Who cannot join

  • Allergy to barium
  • Prior surgery to the head and neck region affecting swallowing-related structures
  • Prior chemotherapy or radiation treatment to the head and neck region
  • Prior cerebral vascular accident with resulting persistent dysphagia
  • Non-English speaking

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin-Madison Hospital and Clinics

    Madison, Wisconsin, 53703

Other trials in United States

About this study

Official title: Elucidating Factors Contributing to Dysphagia in Frail Older Adults

The purpose of this research study is to figure out if there are physical factors such as cognition level, nutrition status, walking speed, and handgrip strength that are associated with the development of swallowing problems. Investigators want to better understand how swallowing problems develop in older adults with and without frailty. Identifying factors that contribute to swallowing problems, can develop therapies in the future to improve swallowing outcomes for older adults.

This study will be done at the University of Wisconsin-Madison (UW-Madison). A total of about 69 people will participate in this study.

Read the detailed description

This study has 3 specific aims:

Aim 1 will determine the presence and severity of dysphagia in a cohort of older adults based on clinical frailty phenotype; Aim 2 will examine the effects of frailty status on physiological measures of swallowing in older adults; and Aim 3 will characterize relationships among specific functional frailty domains and dysphagia status in older adults.

This proposed research will provide a new understanding of the factors that underlie and contribute to dysphagia across clinical frailty phenotypes. Equipped with this knowledge, future treatment and management approaches can be developed to proactively identify dysphagia risk factors in pre-frail and frail individuals so dysphagia can be prevented or adequately addressed. This work is highly significant due to the large and increasing population of aging people who often suffer from debilitating swallowing impairments and may benefit from optimized treatments that can be developed using knowledge gained from this study.

Per approved protocol amendment on 3/39/2022, saliva samples will be collected to explore the composition and structure of oral microbiota via 16S rRNA gene analysis.

Conditions
Dysphagia, Frailty
Keywords
Clinical frailty phenotype
Medical subject headings
Deglutition Disorders, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04975815
Study groupRoleWhat they receive
Non-frail groupParticipants will be assessed using five criteria from the Fried Frailty Index. Index scores"0" will place the participants in Non-frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion.
Pre-frail groupParticipants will be assessed using five criteria from the Fried Frailty Index. Index scores"1-2" will place the participants in Pre-frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion.
Frail groupParticipants will be assessed using five criteria from the Fried Frailty Index. Index scores"3-5" will place the participants in Frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score on Modified Barium Swallow Impairment Profile (MBSImP)

    Dysphagia presence and severity will be examined using the validated Modified Barium Swallow Impairment Profile (MBSImP). Under MBSImP, swallows are assessed via 17 physiologic components pertaining to the oral and pharyngeal phases of swallowing. These individual components are scored from '0' to '5' with higher scores representing greater (worse) impairment within each component. The MBSImP yields total composite scores for the oral and pharyngeal domains as well as an overall impression score which is the worst score across all 17 components.

    Measured: 2 weeks

Secondary outcomes (42)
  1. Number of participants with presence/absence of dysphagia based on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale

    Binary dysphagia status will be operationally defined as: DIGEST <1 = non-dysphagic; DIGEST ≥ 1 = dysphagic based on previous investigations.

    Measured: 2 weeks

  2. Score on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale: Dysphagia severity

    Dysphagia severity will be indexed by DIGEST total scores (0=normal; 1=mild dysphagia; 2=moderate dysphagia; 3=severe dysphagia; 4=life-threatening dysphagia)

    Measured: 2 weeks

  3. Swallowing reaction time (ms)

    From Videofluoroscopic Swallow Studies (VFSS), the swallowing reaction time (ms) will be calculated.

    Measured: 2 weeks

  4. Hyoid burst to upper esophageal sphincter open (ms)

    From VFSS, the hyoid burst to upper esophageal sphincter open (ms) will be calculated.

    Measured: 2 weeks

  5. Upper esophageal sphincter opening duration (ms)

    From VFSS, the upper esophageal sphincter opening duration (ms) will be calculated.

    Measured: 2 weeks

  6. Laryngeal closure reaction time (ms)

    From VFSS, the laryngeal closure reaction time (ms) will be calculated.

    Measured: 2 weeks

  7. Laryngeal closure duration (ms).

    From VFSS, the laryngeal closure reaction duration (ms) will be calculated.

    Measured: 2 weeks

  8. Extent of hyoid movement (mm)

    From Videofluoroscopic Swallow Studies (VFSS), the extent of hyoid movement in mm will be determined

    Measured: 2 weeks

  9. Upper esophageal sphincter (UES) opening width (mm)

    From Videofluoroscopic Swallow Studies (VFSS), the width of UES opening width in mm will be determined.

    Measured: 2 weeks

  10. Pixel-based measure of pharyngeal residue (%C2-C4 squared)

    The analysis of swallowing physiology will include a pixel-based measure of pharyngeal residue. Residue will be traced and compared with an anatomic reference scalar (squared length of the C2-4 cervical spine),

    Measured: 2 weeks

  11. Pharyngeal constriction ratio (PCR)

    The 'Pharyngeal Constriction Ratio' (PCR), a pixel-based measure made on lateral view videofluoroscopy swallow study (VFSS) frames. The PCR is calculated by tracing the unobliterated area of the pharynx (including the bolus) at the point of maximum constriction during the swallow and then dividing that area by a corresponding area measure when the pharynx is at rest.

    Measured: 2 weeks

  12. Masticatory efficiency evaluated by Test of Masticating and Swallowing Solids (TOMASS)

    The Test of Masticating and Swallowing Solids (TOMASS) was developed as a quantitative assessment of solid bolus ingestion. Participants will be instructed to eat a single portion of a cracker "as quickly as is comfortably possible and when you have finished, say your name out loud". Two independent raters will observe a lateral view of the face and count masticatory cycles by observing jaw movements. Timing of the entire task will be recorded using a stopwatch. Longer mastication times/more masticatory cycles required to eat the cracker are a worse outcomes.

    Measured: 2 weeks

  13. Number of participants assessed as pass/fail the three ounce water swallow test

    Participants will be recorded as "passing" the three ounce water swallow test if they drank the water uninterrupted without coughing, choking, or without presence of a wet/gurgly voice during or immediately after drinking. If a participant stops drinking before finishing the three ounces, has coughing, choking or a wet/gurgly voice during or immediately after drinking, they will be recorded as "failing" this screen.

    Measured: 2 weeks

  14. Pharyngeal Pressure Outcome: Integral pressure (mmHg*time)

    Integral pressure will be measured in velopharynx, tongue base, hypopharynx. Maximum pressure = the maximum amount of pressure generated at each of these corresponding sensors during the exam.

    Duration = the amount of time pressure is generated at each sensor during the trials.

    Integral pressure= a summary measure of maximum pressure x time.

    Measured: 2 weeks

  15. Pharyngeal Pressure Outcome: Pharyngeal contractile integral (PhCI)

    PhCI is a measure of the "vigor" of the pharyngeal contraction, taking into consideration the pressure amplitude, duration and length of the pharyngeal contraction.

    Measured: 2 weeks

  16. Pharyngeal Pressure Outcome: Total swallow duration

    Total swallow duration = the total amount of time from pressure onset to pressure offset during a manometry bolus trial.

    Measured: 2 weeks

  17. Lingual Pressure Outcome: Mean slope (kpa/seconds)

    Slope (kpa/seconds) is the lingual pressure range to maximum lingual pressure over time.

    Measured: Day 0

  18. Lingual Pressure Outcome: Maximum lingual pressure

    The maximum lingual pressure is also referred to as maximum anterior isometric lingual pressure (MAIP) and it is the highest lingual pressure recorded during the trial.

    Measured: Day 0

  19. Lingual Pressure Outcome: Saliva swallow pressure

    Saliva swallow pressure is the highest saliva swallowing pressure taken during a saliva pressure trial. Investigators will be taking an average of these 3 values to get the mean.

    Measured: Day 0

  20. Lingual Pressure Outcome: Cyclic spatiotemporal index (CSTI)

    Cyclic spatiotemporal index represents a measure of pattern variability across repeated trials. Peaks and valleys in each task repetition are amplitude- and time-normalized and aligned with each other. An inbuilt algorithm within the MATLAB program then calculate standard deviations (SDs) across these peak and valley segments at successive 2% intervals, across 50 values per task repetition. The CSTI is then defined as the sum of these SDs with higher CSTI values representing greater pattern variability across the three MAIP trials. Mean CSTI was used in data analysis.

    Measured: Day 0

  21. Lingual Pressure Outcome: Cycle duration

    Cycle duration is the total time of the lingual pressure trial from pressure onset to pressure offset.

    Measured: Day 0

  22. Respiratory Measurement: Maximum expiratory pressure(MEP)

    MEP (maximum expiratory pressure): the maximum amount of air the patient breathes out during a trial.

    The highest MEP across trials will be recorded for each participant.

    Measured: Day 0

  23. Respiratory Measurement: Maximum inspiratory pressure (MIP)

    MIP (maximum inspiratory pressure): the maximum amount of air the patient breathes in during a trial. The highest MIP across trials will be recorded for each participant.

    Measured: Day 0

  24. Respiratory Measurement: Maximum Forced vital capacity (FVC)

    FVC (forced vital capacity): a surrogate measure of lung volume; maximum amount of air a person can breathe out following a maximum inhalation.

    The highest FVC across trials will be recorded for each participant.

    Measured: Day 0

  25. Respiratory Measurement: Forced Expiratory Volume in 1 second (FEV1)

    The FEV1 associated with the highest FVC will be reported.

    Measured: Day 0

  26. Respiratory Measurement: FEV1/FVC Ratio

    FEV1/FVC ratio associated with the highest FVC will be reported.

    Measured: Day 0

  27. Respiratory Measurement: Peak Expiratory Flow (PEF)

    The PEF associated with the highest FVC will be reported.

    Measured: Day 0

  28. Salivary flow rate (grams/minute)

    Salivary flow rate will be determined by the change in collection vial weight over 5 minutes for both unstimulated and stimulated conditions (grams/minute).

    Measured: 2 weeks

  29. Extensional viscosity of saliva

    Compositional analyses will measure apparent extensional viscosity (ηapp(ɛ))^33 of saliva.

    Measured: 2 weeks

  30. Time to break up saliva(ms)

    Measured: 2 weeks

  31. Salivary pH

    Salivary pH will be measured using a digital pH meter.

    Measured: 2 weeks

  32. Mini Nutritional Assessment Score

    Nutritional status will be determined for each participant in accordance with scoring guidelines for the Mini Nutritional Assessment. The scale yields a total score out of 30 with higher scores representing more intact/healthy nutritional status. A total score of 24-30 is considered normal nutritional status, scores of 17-23.5 represent risk of malnutrition, and scores <17 indicate malnutrition.

    Measured: Day 0

  33. Body Mass Index (BMI)

    Participant's weight and height will be combined to calculate BMI in kg/m^2. Participants will be categorized into the following standardized categories: 1) <18.5kg/m^2: underweight; 2) 18.5-24.9kg/m^2: normal/healthy weight; 3) 25-29.9kg/m^2: overweight; 4) ≥30kg/m^2: obese.

    Measured: Day 0

  34. Limb function outcome: average handgrip strength

    The average handgrip strength across the three trials for each participant will be recorded and utilized in subsequent data analysis.

    Measured: Day 0

  35. Gate analysis: cadence (steps per minute)

    Measured: Day 0

  36. Gate analysis: normalized walking velocity

    Measured: Day 0

  37. Gate analysis: normalized base of support

    Measured: Day 0

  38. Gate analysis: step extremity ratio

    Measured: Day 0

  39. Gate analysis: percentage of the gait cycle spent in double support time

    Measured: Day 0

  40. Presence/absence of exhaustion

    Exhaustion will be considered present if a participant answers "a moderate amount of the time" or "most of the time" to this question: "How often in the last week did you feel this way?".

    Measured: Day 0

  41. Total physical activity measured as kilocalories expended per week

    A weighted estimate of total physical activity (MET-minutes per week) from all reported activities per week will be obtained through the sum of the duration of the activity × frequency per week × MET intensity of each activity domain included in the questionnaire, which will then be converted to kilocalories expended per week.

    Measured: Day 0

  42. Montreal Cognitive Assessment (MoCA) score

    Cognitive status will be determined by total MoCA scores. A total MoCA score of 26-30 is considered normal (no impairment); scores of 18-25 represent a mild cognitive impairment; scores of 10-17 represent a moderate cognitive impairment; and scores <10 a severe.

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start6 Apr 2022
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04975815
Sponsor's protocol ID
2021-0536
Other IDs
A534255, SMPH/MEDICINE/GER-AD DEV, 1K76AG068590-01, Protocol Amend 11/7/2023, 8K00AG076123-03
Status last verified
Jul 2026
First submitted
14 Jul 2021
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dysphagia and Frailty, run by University of Wisconsin, Madison 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 4 inclusion and 5 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 9 Jul 2026. 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?

Score on Modified Barium Swallow Impairment Profile (MBSImP) (time frame: 2 weeks). 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 9 Jul 2026.

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