Frailty and Dysphagia in Older Adults

University of Wisconsin (UW)

Status: Active, not recruiting

Conditions: Dysphagia; Frailty

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04975815

SMPH/MEDICINE/GER-AD DEV (Other Identifier)

Protocol Amend 11/7/2023 (Other Identifier)

1K76AG068590-01 (U.S. NIH Grant/Contract)

A534255 (Other Identifier)

2021-0536

8K00AG076123-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

52 participants in 3 patient groups

Non-frail group

Description:

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.

Pre-frail group

Description:

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.

Frail group

Description:

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.