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Dysphagia Risk in Rheumatic Diseases

Assessment of Dysphagia Risk in Individuals With Inflammatory Rheumatic Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07504900
Enrollment
191
Registered
2026-04-01
Start date
2025-09-15
Completion date
2026-04-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Rheumatic Diseases

Brief summary

This study aims to evaluate the impact of dysphagia on eating and swallowing functions, gastrointestinal symptoms, and related clinical findings in individuals with inflammatory rheumatic diseases. Additionally, the study aims to identify differences between individuals with and without dysphagia.

Interventions

None listed

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Having a diagnosis of a rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, etc.) * Being 18 years of age or older * Having the cognitive ability to answer the questionnaires * Volunteering to participate in the study

Exclusion criteria

* Having any neurological or psychological disorder that may prevent participation * Having a psychiatric disorder severe enough to affect cooperation * Being hospitalized during an acute flare * History of active gastrointestinal surgery within the last 3 months

Design outcomes

Primary

MeasureTime frameDescription
Eating Assessment Tool (EAT-10)at baselineThe primary outcome is the risk of dysphagia in patients with inflammatory rheumatic diseases, measured using a validated questionnaire administered once to each participant. The swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10). The scale consists of 10 items, with a total score ranging from 0 to 40. Higher scores indicate a greater severity of swallowing impairment (a score of ≥3 is considered indicative of dysphagia)
Fonseca Anamnestic Questionnaireat baselineThe severity of temporomandibular disorders was assessed using the Fonseca Anamnestic Index (FAI). The index consists of 10 items with a total score ranging from 0 to 100. Higher scores indicate a greater severity of temporomandibular dysfunction
Gastrointestinal Symptom Rating Scale (GSRS)at baselineGastrointestinal symptoms were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS). The scale consists of 15 items scored on a 7-point Likert scale ranging from 1 to 7. Total and subscale scores are calculated, where higher scores indicate greater symptom severity and a worse clinical condition.
Functional Oral Intake Scale (FOIS)at baselineThe patient's functional level of oral intake was assessed using the Functional Oral Intake Scale (FOIS). The scale is a 7-point ordinal scale with scores ranging from 1 to 7. Unlike many other clinical tools, higher scores on the FOIS indicate better functional oral intake, with a score of 1 representing total tube dependency and a score of 7 representing total oral intake with no restrictions.
Mediterranean Diet Quality Index (KIDMED)at baselineNutritional habits and adherence to the Mediterranean diet were evaluated using the Mediterranean Diet Quality Index (KIDMED). The index is based on a 16-item questionnaire with total scores ranging from -4 to 12. Higher scores indicate better adherence to the Mediterranean diet and higher dietary quality.
Reflux Symptom Index (RSI)at baselineThe severity of laryngopharyngeal reflux symptoms was assessed using the Reflux Symptom Index (RSI). The index is a 9-item self-reported questionnaire with a total score ranging from 0 to 45. Higher scores indicate a greater severity of symptoms, with a score of 13 or higher typically considered as clinically significant for reflux.
Malnutrition Inflammation Scoreat baselineNutritional status and inflammation levels were assessed using the Malnutrition-Inflammation Score (MIS). The score consists of 10 components, including clinical history, physical examination, body mass index, and laboratory parameters (serum albumin and total iron-binding capacity). Each component is scored from 0 to 3, with total scores ranging from 0 to 30. Higher scores indicate a greater severity of malnutrition and inflammation.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026