Clinical trial NCT04975815: Frailty and Dysphagia in Older Adults
Official title: Elucidating Factors Contributing to Dysphagia in Frail Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Frailty
Keywords: Clinical frailty phenotype
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-23
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Score on Modified Barium Swallow Impairment Profile (MBSImP)
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of participants with presence/absence of dysphagia based on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale
timeFrame: 2 weeks
measure: Score on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale: Dysphagia severity
timeFrame: 2 weeks
measure: Swallowing reaction time (ms)
timeFrame: 2 weeks
measure: Hyoid burst to upper esophageal sphincter open (ms)
timeFrame: 2 weeks
measure: Upper esophageal sphincter opening duration (ms)
timeFrame: 2 weeks
measure: Laryngeal closure reaction time (ms)
timeFrame: 2 weeks
measure: Laryngeal closure duration (ms).
timeFrame: 2 weeks
measure: Extent of hyoid movement (mm)
timeFrame: 2 weeks
measure: Upper esophageal sphincter (UES) opening width (mm)
timeFrame: 2 weeks
measure: Pixel-based measure of pharyngeal residue (%C2-C4 squared)
timeFrame: 2 weeks
measure: Pharyngeal constriction ratio (PCR)
timeFrame: 2 weeks
measure: Masticatory efficiency evaluated by Test of Masticating and Swallowing Solids (TOMASS)
timeFrame: 2 weeks
measure: Number of participants assessed as pass/fail the three ounce water swallow test
timeFrame: 2 weeks
measure: Pharyngeal Pressure Outcome: Integral pressure (mmHg*time)
timeFrame: 2 weeks
measure: Pharyngeal Pressure Outcome: Pharyngeal contractile integral (PhCI)
timeFrame: 2 weeks
measure: Pharyngeal Pressure Outcome: Total swallow duration
timeFrame: 2 weeks
measure: Lingual Pressure Outcome: Mean slope (kpa/seconds)
timeFrame: Day 0
measure: Lingual Pressure Outcome: Maximum lingual pressure
timeFrame: Day 0
measure: Lingual Pressure Outcome: Saliva swallow pressure
timeFrame: Day 0
measure: Lingual Pressure Outcome: Cyclic spatiotemporal index (CSTI)
timeFrame: Day 0
measure: Lingual Pressure Outcome: Cycle duration
timeFrame: Day 0
measure: Respiratory Measurement: Maximum expiratory pressure(MEP)
timeFrame: Day 0
measure: Respiratory Measurement: Maximum inspiratory pressure (MIP)
timeFrame: Day 0
measure: Respiratory Measurement: Maximum Forced vital capacity (FVC)
timeFrame: Day 0
measure: Respiratory Measurement: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Day 0
measure: Respiratory Measurement: FEV1/FVC Ratio
timeFrame: Day 0
measure: Respiratory Measurement: Peak Expiratory Flow (PEF)
timeFrame: Day 0
measure: Salivary flow rate (grams/minute)
timeFrame: 2 weeks
measure: Extensional viscosity of saliva
timeFrame: 2 weeks
measure: Time to break up saliva(ms)
timeFrame: 2 weeks
measure: Salivary pH
timeFrame: 2 weeks
measure: Mini Nutritional Assessment Score
timeFrame: Day 0
measure: Body Mass Index (BMI)
timeFrame: Day 0
measure: Limb function outcome: average handgrip strength
timeFrame: Day 0
measure: Gate analysis: cadence (steps per minute)
timeFrame: Day 0
measure: Gate analysis: normalized walking velocity
timeFrame: Day 0
measure: Gate analysis: normalized base of support
timeFrame: Day 0
measure: Gate analysis: step extremity ratio
timeFrame: Day 0
measure: Gate analysis: percentage of the gait cycle spent in double support time
timeFrame: Day 0
measure: Presence/absence of exhaustion
timeFrame: Day 0
measure: Total physical activity measured as kilocalories expended per week
timeFrame: Day 0
measure: Montreal Cognitive Assessment (MoCA) score
timeFrame: Day 0
Other outcomes:
measure: Summary Composition of buccal, mucosal, and tongue dorsum microbial communities
timeFrame: 2 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Nicole M Rogus-Pulia, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: