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Not yet recruitingNCT07816276Updated Sep 11, 2026

THE EFFECTS OF MULTIPLE DRUG USE ON BALANCE, FALL RISK, AND COGNITIVE STATUS

An observational study in Polypharmacy (Individuals Treated With 4 or More Medications), sponsored by Ondokuz Mayıs University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 60 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Ondokuz Mayıs University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
50
Ages
60 Years to 99 Years
Sex
All
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Study summary

This study aims to evaluate the effects of polypharmacy on balance, fall risk, cognitive status, vestibular function, and hearing among individuals living in nursing homes. The study investigates the relationship between polypharmacy and balance, fall risk, cognitive, vestibular, and hearing-related outcomes.

Read the detailed description

This study aims to investigate the effects of polypharmacy on balance, fall risk, cognitive status, vestibular function, and hearing in individuals living in nursing homes. The study will evaluate the potential relationships between polypharmacy and cognitive status, balance performance, fall risk, vestibular functions, and hearing outcomes. Participants will undergo detailed assessments (Standardized Mini-Mental State Examination, Berg Balance Scale, Tinetti Test, Timed Up and Go Test, Functional Reach Test, Cognitive Vestibular Function Scale, and pure tone audiometry); the findings will be compared with control group data and analyzed.

02

Conditions studied

  • Polypharmacy (Individuals Treated With 4 or More Medications)

Keywords

  • Berg Balance Scale, Cognitive Vestibular Scale, Balance, Geriatric Individual, Mini-Mental State Examination, Polypharmacy
03

Who can participate

Ages eligible
60 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population consisted of individuals aged 60 years and older living in nursing homes in Samsun. Participants were divided into two groups according to medication use: a polypharmacy group and a control group. All participants were able to walk independently, communicate verbally, and complete the study assessments.

Inclusion criteria

  • Individuals aged 60 years and older
  • Individuals living in nursing homes in Samsun
  • Individuals in the polypharmacy group using the defined number of medications and individuals in the control group using fewer or no medications
  • Ability to walk independently without an assistive device
  • Ability to communicate verbally
  • Voluntary participation in the study
  • No complaint or diagnosis of vestibular disorder
  • Ability to read and write

Exclusion criteria

Exclusion Criteria:

  • Individuals younger than 60 years
  • Severe dementia
  • Use of an assistive walking device
  • Central nervous system or visual pathologies that may affect balance
  • Previous diagnosis of vestibular pathology
  • History of severe neurological diseases such as stroke
  • Inability to provide reliable responses to the assessments
  • Inability to cooperate with the assessment procedures
  • Inability to read and write
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study Group

    Polypharmacy Group: Individuals living in nursing homes who use four or more medications.

  • Control Group

    Control Group: Individuals living in nursing homes who use fewer than four medications or no medications.

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What researchers measure

Primary outcomes

  1. Standardized Mini-Mental State Examination

    Description: Individuals' cognitive status was assessed using the Standardized Mini-Mental State Examination and compared between the polypharmacy group and the control group.

    Time frame: Baseline

  2. Cognitive-Vestibular Function Scale

    Individuals' cognitive-vestibular functions were assessed using the Cognitive-Vestibular Function Scale and compared between the polypharmacy group and the control group.

    Time frame: Baseline

Secondary outcomes

  1. 6-Meter Walk Test

    Description: Individuals' gait speed was assessed using the 6-Meter Walk Test and compared between the polypharmacy group and the control group.

    Time frame: Baseline

  2. Functional Reach Test

    Description: Individuals' dynamic balance and functional reach performance were assessed using the Functional Reach Test and compared between the polypharmacy group and the control group.

    Time frame: Baseline

  3. Timed Up and Go Test

    Description: Individuals' functional mobility and fall risk were assessed using the Timed Up and Go Test and compared between the polypharmacy group and the control group.

    Time frame: Baseline

  4. Tinetti Balance and Gait Test

    Description: Individuals' balance and gait performance were assessed using the Tinetti Balance and Gait Test and compared between the polypharmacy group and the control group.

    Time frame: Baseline

  5. Berg Balance Scale

    Description: Individuals' balance performance was assessed using the Berg Balance Scale and compared between the polypharmacy group and the control group.

    Time frame: Baseline

Other outcomes

  1. Pure-Tone Audiometry Hearing Thresholds

    Description: Hearing thresholds were assessed by pure-tone audiometry at 250, 500, 1000, 2000, and 4000 Hz in both ears and compared between the study and control groups.

    Time frame: Baseline

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Study locations

1 site
  • Ondokuz Mayıs University
    Samsun, Samsun 55139, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers. Only aggregate study results will be reported in the publication.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07816276
Lead sponsor
Ondokuz Mayıs University
Responsible party
Handan Turan Dizdar (ASSISTANT PROFESSOR, Ondokuz Mayıs University) — Principal investigator
First posted
Sep 11, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Handan TURAN DİZDAR, PhD
Contact
handan.dizdar@omu.edu.tr
+90 505 597 06 27
İrem NECİPOĞLU
Contact
ncp.irem9@gmail.com
+905456580233
Handan TURAN DİZDAR, PhD
principal investigator · Ondokuz Mayıs University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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