NCT07813143

Brief Summary

Falls are common among older adults and can lead to serious injury. This study looks at whether taking many medications (polypharmacy), the anticholinergic burden of those medications (a measure of side effects that can affect memory, balance, and muscle function), and sarcopenia (age-related loss of muscle mass and strength) are related to fall risk in older adults visiting the emergency department. Patients aged 65 and older who come to the emergency department will be invited to take part. With their consent, researchers will review the medications they are taking and calculate an anticholinergic burden score. Researchers will also measure the patients' hand grip strength and use ultrasound to measure the thickness of the quadriceps muscle in the thigh, both of which are used to assess muscle health. Information about the patients' history of falls in the past year, hospital stays, and other health conditions will also be collected. All measurements are non-invasive, are already used in routine clinical practice, and are performed only once during the emergency department visit. No experimental treatment or medication will be given as part of this study. The goal of this study is to understand how polypharmacy, anticholinergic burden, and sarcopenia relate to fall risk, both individually and together, so that older adults at higher risk of falling can be identified earlier and offered appropriate prevention strategies.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Completed
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

July 29, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

FallsSarcopeniaGeriatricAnticholinergics burden

Outcome Measures

Primary Outcomes (3)

  • Association Between Fall History and Polypharmacy Status

    Fall history within the preceding 12 months will be evaluated in relation to polypharmacy status, defined as concurrent use of ≥5 medications, assessed via medication reconciliation. Measure: proportion of patients with polypharmacy (%) among fallers vs. non-fallers.

    Baseline

  • Association Between Fall History and Anticholinergic Burden

    Fall history within the preceding 12 months will be evaluated in relation to polypharmacy status, defined as concurrent use of ≥5 medications, assessed via medication reconciliation. Measure: proportion of patients with polypharmacy (%) among fallers vs. non-fallers.

    Baseline

  • Association Between Fall History and Probable Sarcopenia

    Fall history within the preceding 12 months will be evaluated in relation to probable sarcopenia, defined per EWGSOP2 criteria using hand-grip strength (measured by handheld dynamometer, kg) and combined quadriceps muscle thickness (measured by ultrasound, mm). Measure: proportion of patients meeting probable sarcopenia criteria (%) among fallers vs. non-fallers.

    Baseline

Secondary Outcomes (4)

  • Hand-grip strength

    Baseline

  • Combined quadriceps muscle thickness (CMT)

    Baseline

  • Anticholinergic Burden Scale (ACB) score

    Baseline

  • Number of concurrent medications (polypharmacy status)

    Baseline

Study Arms (1)

Geriatric ED Patients

atients aged 65 years or older presenting to the emergency department, in whom polypharmacy, anticholinergic burden (ACB score), hand-grip strength, and quadriceps muscle thickness (ultrasound) are assessed to evaluate their relationship with fall risk and clinical outcomes. No study intervention is administered; all measurements reflect routine clinical assessment performed once at the time of ED presentation.

Eligibility Criteria

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

Patients aged 65 years and older presenting to the Emergency Department of Gazi University Hospital, enrolled consecutively based on eligibility criteria.

You may qualify if:

  • Age 65 years or older
  • Presenting to the emergency department
  • Willing and able to provide written informed consent

You may not qualify if:

  • Prior major upper or lower extremity surgery, prosthesis, or amputation preventing ultrasound or hand-grip strength measurement
  • Acute bilateral femur or hip fracture precluding measurement
  • Neuromuscular disease (e.g., ALS, myopathy)
  • Terminal or palliative status with limited ability to cooperate with measurements
  • Severe delirium or inability to cooperate with hand-grip testing
  • ECOG Performance Status of 3 or 4
  • Bedbound status and/or stroke sequelae preventing assessment
  • Patients who decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Wang JC, Wu WT, Chang KV, Chen LR, Chi SY, Kara M, Ozcakar L. Ultrasound Imaging for the Diagnosis and Evaluation of Sarcopenia: An Umbrella Review. Life (Basel). 2021 Dec 22;12(1):9. doi: 10.3390/life12010009.

    PMID: 35054402BACKGROUND
  • Stewart C, Taylor-Rowan M, Soiza RL, Quinn TJ, Loke YK, Myint PK. Anticholinergic burden measures and older people's falls risk: a systematic prognostic review. Ther Adv Drug Saf. 2021 May 31;12:20420986211016645. doi: 10.1177/20420986211016645. eCollection 2021.

    PMID: 34104401BACKGROUND
  • Ozturk Y, Koca M, Burkuk S, Unsal P, Dikmeer A, Oytun MG, Bas AO, Kahyaoglu Z, Deniz O, Coteli S, Ileri I, Dogu BB, Cankurtaran M, Halil M. The role of muscle ultrasound to predict sarcopenia. Nutrition. 2022 Sep;101:111692. doi: 10.1016/j.nut.2022.111692. Epub 2022 Apr 22.

    PMID: 35660496BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assc. prof.

Study Record Dates

First Submitted

July 29, 2026

First Posted

September 10, 2026

Study Start

June 1, 2026

Primary Completion

July 15, 2026

Study Completion

September 15, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09

Locations