Frailty and Dysphagia in Older Adults

NCT04975815 | Completed

• 6 other identifiers: 2021-0536A534255SMPH/MEDICINE/GER-AD DEV1K76AG068590-01Protocol Amend 11/7/20238K00AG076123-03
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Frailty

Keywords

Clinical frailty phenotype

Outcome Measures

Primary Outcomes (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.

  2 weeks

Secondary Outcomes (42)

• Number of participants with presence/absence of dysphagia based on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale

  2 weeks

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

  2 weeks

• Swallowing reaction time (ms)

  2 weeks

• Hyoid burst to upper esophageal sphincter open (ms)

  2 weeks

• Upper esophageal sphincter opening duration (ms)

  2 weeks

Other Outcomes (1)

• Summary Composition of buccal, mucosal, and tongue dorsum microbial communities

  2 weeks

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin-Madison Hospital and Clinics

Madison, Wisconsin, 53703, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Frailty

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole M Rogus-Pulia, PhD, CCC-SLP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: April 6, 2022
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)