NCT06491407

Brief Summary

Various structural and functional problems in neural, sensory and perceptual, cardiovascular, pulmonary, gastrointestinal, endocrine, and musculoskeletal systems occur in geriatrics not associated with a specific disease. One of the problems observed in geriatrics is chewing and swallowing disorders. Failure to detect changes in chewing and swallowing performance in elderly individuals at an early stage may lead to chewing and swallowing disorders and serious complications in later stages. Therefore, it is necessary to comprehensively and systematically address the possible factors affecting chewing and swallowing performance in geriatric individuals. The first aim of the study is to analyze the factors affecting chewing and swallowing performance in geriatric individuals within the scope of the International Classification of Functioning, Disability, and Health (ICF). The second aim of the study is to create a dysphagia risk prediction model for geriatric individuals based on the results of the analyses to be conducted. In the study, the dependent variables, chewing performance, will be evaluated with the Chewing and Swallowing Test of Solids, and swallowing performance will be assessed with the Repetitive Saliva Swallowing Test and Dysphagia Limit. Independent variables affecting chewing and swallowing performance have been considered within the scope of the ICF, and all possible factors determined for both geriatrics and swallowing have been listed, and the evaluation parameters and assessment tools have been decided. The evaluation parameters have been categorized under ICF headings such as personal factors, body structures, body functions, activity and participation, and environmental factors, and the evaluations to be conducted have been divided into two groups: geriatric and physiotherapy evaluations. The geriatric evaluations are part of routine geriatric assessment and do not include any specific evaluation for the study. Physiotherapy evaluations will be applied in a certain order to use time efficiently and will take approximately 35-45 minutes. Through geriatric and physiotherapy evaluations, a holistic assessment of participants within the scope of ICF will be ensured.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 1, 2024

Last Update Submit

July 1, 2024

Conditions

Keywords

swallowchewinggeriatricsrisk factor

Outcome Measures

Primary Outcomes (2)

  • Chewing performance

    1 day

  • Swallowing performance

    1 day

Secondary Outcomes (29)

  • Deccriptive informations

    1 day

  • Fragility Assessment

    1 day

  • posture assessment

    1 day

  • oral structure assessment

    1 day

  • cognitive assessment

    1 day

  • +24 more secondary outcomes

Study Arms (1)

Geriatrics

\>65 years old individuals

Diagnostic Test: Chewing and swallowing performance assessment and related factors

Interventions

In the study, the dependent variables, chewing performance, will be evaluated with the Chewing and Swallowing Test of Solids, and swallowing performance will be assessed with the Repetitive Saliva Swallowing Test and Dysphagia Limit. Independent variables affecting chewing and swallowing performance have been considered within the scope of the ICF, and all possible factors determined for both geriatrics and swallowing have been listed, and the evaluation parameters and assessment tools have been decided.

Geriatrics

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Geriatrics over the age of 65 who come for routine examination for Hacettepe University Hospital Geriatri Clinis will be included in the study.

You may qualify if:

  • being voluntary to participation,
  • Being over 65 years old,
  • Understanding and following simple instructions,
  • Being able to walk independently for 4 meters.

You may not qualify if:

  • Having a problem that prevents communication and/or following simple instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım Uiveristy

Ankara, Incek, 06830, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Mastication

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Selen serel arslan, Prof

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

sena N begen, MSc

CONTACT

sena N begen, msc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

February 1, 2024

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations