Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2022-04-06
2025-03-14
Brief Summary
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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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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-frail group
Participants 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.
No interventions assigned to this group
Pre-frail group
Participants 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.
No interventions assigned to this group
Frail group
Participants 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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Nicole M Rogus-Pulia, PhD, CCC-SLP
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin-Madison Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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A534255
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/GER-AD DEV
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Amend 11/7/2023
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0536
Identifier Type: -
Identifier Source: org_study_id
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