University of Wisconsin-Madison Hospital and Clinics
Madison, Wisconsin, 53703, United States
NCT Number: NCT04975815
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.
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Notify Me65 year and older
All sexes
Observational
Madison, Wisconsin, 53703, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 weeks
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.
Time frame: 2 weeks
Binary dysphagia status will be operationally defined as: DIGEST <1 = non-dysphagic; DIGEST ≥ 1 = dysphagic based on previous investigations.
Time frame: 2 weeks
Dysphagia severity will be indexed by DIGEST total scores (0=normal; 1=mild dysphagia; 2=moderate dysphagia; 3=severe dysphagia; 4=life-threatening dysphagia)
Time frame: 2 weeks
From Videofluoroscopic Swallow Studies (VFSS), the swallowing reaction time (ms) will be calculated.
Time frame: 2 weeks
From VFSS, the hyoid burst to upper esophageal sphincter open (ms) will be calculated.
Time frame: 2 weeks
From VFSS, the upper esophageal sphincter opening duration (ms) will be calculated.
Time frame: 2 weeks
From VFSS, the laryngeal closure reaction time (ms) will be calculated.
Time frame: 2 weeks
From VFSS, the laryngeal closure reaction duration (ms) will be calculated.
Time frame: 2 weeks
From Videofluoroscopic Swallow Studies (VFSS), the extent of hyoid movement in mm will be determined
Time frame: 2 weeks
From Videofluoroscopic Swallow Studies (VFSS), the width of UES opening width in mm will be determined.
Time frame: 2 weeks
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),
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
PhCI is a measure of the "vigor" of the pharyngeal contraction, taking into consideration the pressure amplitude, duration and length of the pharyngeal contraction.
Time frame: 2 weeks
Total swallow duration = the total amount of time from pressure onset to pressure offset during a manometry bolus trial.
Time frame: Day 0
Slope (kpa/seconds) is the lingual pressure range to maximum lingual pressure over time.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: Day 0
Cycle duration is the total time of the lingual pressure trial from pressure onset to pressure offset.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: Day 0
The FEV1 associated with the highest FVC will be reported.
Time frame: Day 0
FEV1/FVC ratio associated with the highest FVC will be reported.
Time frame: Day 0
The PEF associated with the highest FVC will be reported.
Time frame: 2 weeks
Salivary flow rate will be determined by the change in collection vial weight over 5 minutes for both unstimulated and stimulated conditions (grams/minute).
Time frame: 2 weeks
Compositional analyses will measure apparent extensional viscosity (ηapp(ɛ))^33 of saliva.
Time frame: 2 weeks
Time frame: 2 weeks
Salivary pH will be measured using a digital pH meter.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: Day 0
The average handgrip strength across the three trials for each participant will be recorded and utilized in subsequent data analysis.
Time frame: Day 0
Time frame: Day 0
Time frame: Day 0
Time frame: Day 0
Time frame: Day 0
Time frame: Day 0
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?".
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: 2 weeks
The composition and structure of the oral microbiota will then be determined via 16S rRNA gene analysis.
University of Wisconsin, Madison
Other
Elucidating Factors Contributing to Dysphagia in Frail Older Adults
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