Falls (Accidents) in Old AgeNCT07813143
Evaluation of the Relationship Between Fall Risk, Muscle Strength, and Anticholinergic Burden in Geriatric Patients Presenting to the Emergency Department
An observational study of Falls (Accidents) in Old Age and Falls, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls (Accidents) in Old Age, Falls, Anticholinergics
- How many people
- 333 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years and older presenting to the Emergency Department of Gazi University Hospital, enrolled consecutively based on eligibility criteria.
Who may be able to join
- Age 65 years or older
- Presenting to the emergency department
- Willing and able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Falls are a leading cause of morbidity, injury, and increased health care utilization among older adults presenting to the emergency department. Polypharmacy, high anticholinergic medication burden, and sarcopenia have each been independently associated with increased fall risk in older populations, but their combined and possibly synergistic effect in the acute emergency department setting has not been well characterized.
This is a single-center, prospective, cross-sectional observational study conducted at the Department of Emergency Medicine, Gazi University Faculty of Medicine. Patients aged 65 years or older presenting to the emergency department will be screened for eligibility. After initial evaluation by the treating physician, eligible patients will be informed about the study by a member of the research team, and those who provide written informed consent will be enrolled.
Exclusion criteria include: prior major upper or lower extremity surgery, prosthesis, or amputation that would prevent ultrasound or hand-grip measurement; acute bilateral femur or hip fracture; 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; and bedbound status or stroke sequelae preventing assessment.
Data collection. Using a study-specific case report form, the following will be recorded at the time of the emergency department visit: age, sex, number of comorbidities, fall history over the preceding 12 months, and prior hospitalization history. All medications currently used by the patient - prescription, over-the-counter, and herbal - will be documented. Concurrent use of 5 or more medications will be classified as polypharmacy, and 10 or more as excessive polypharmacy. Anticholinergic burden will be calculated using the Anticholinergic Burden Scale (ACB), with a total score of 3 or higher defined as high anticholinergic burden. Functional status and frailty will be assessed using the Clinical Frailty Scale (CFS) and the ECOG Performance Status scale.
Muscle assessment. Hand grip strength will be measured using a hand dynamometer, and patients will be classified as probable sarcopenia (+) or probable sarcopenia (-) based on this measurement. Quadriceps muscle thickness will be assessed by point-of-care ultrasound (GE Healthcare Venue Point of Care) using a linear probe, with the patient in the supine position. Measurements will be taken at the midpoint between the anterior superior iliac spine and the patella, on the anterior thigh. Rectus femoris (RF) and vastus intermedius (VI) thickness will be measured separately, and combined muscle thickness (CMT) - the distance between the subcutaneous fat layer and the femoral cortex - will be recorded in millimeters. Sarcopenia will be defined according to EWGSOP2 criteria.
Ultrasound measurements will be performed by two emergency medicine residents with prior basic ultrasound training, following a standardized 4-hour theoretical and hands-on training session delivered by an emergency medicine faculty member with 8 years of point-of-care ultrasound experience. A pilot phase involving 20 patients per trained resident will be used to confirm image quality and measurement adequacy before full enrollment begins. All ultrasound images will be stored and reviewed by emergency medicine faculty; measurements with inadequate image quality will be excluded from analysis, though other adequate-quality extremity data from the same patient will still be included.
Outcomes. The relationship between polypharmacy, anticholinergic burden, and sarcopenia parameters (muscle thickness and grip strength) and fall risk and clinical outcomes (major injury, hospital admission, emergency department length of stay, need for consultation) will be evaluated using multivariable statistical methods. No study-specific interventions, treatments, or additional laboratory tests will be performed; all assessments are one-time and use measurements already standard in routine clinical care. Findings will be reported in accordance with the STROBE guidelines for observational studies.
Based on a reported 12-month fall incidence of 37.2% among older adults in Turkey and expected annual enrollment volumes, a minimum sample size of 313 patients (157 male, 156 female) was calculated for this study.
- Conditions
- Falls (Accidents) in Old Age, Falls, Anticholinergics, Sarcopenia, Geriatric
- Keywords
- Falls, Sarcopenia, Geriatric, Anticholinergics burden
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (4)
Hand-grip strength
Measured using a hand dynamometer; used to classify patients as probable sarcopenia (+) or (-).
Measured: Baseline
Combined quadriceps muscle thickness (CMT)
Rectus femoris and vastus intermedius thickness measured by point-of-care ultrasound, recorded in millimeters.
Measured: Baseline
Anticholinergic Burden Scale (ACB) score
Calculated by summing the ACB score of all medications currently used by the patient.
Calculated by summing the Anticholinergic Burden (ACB) score of all medications currently used by the patient, using the ACB calculator (acbcalc.com), which combines the German Anticholinergic Burden scale and the Anticholinergic Cognitive Burden Scale (the higher of the two values is taken when they differ). Each medication is scored from 0 to 3 based on its anticholinergic potency, and scores are summed across all medications; higher total scores indicate greater anticholinergic burden. A total score of 3 or higher is associated with increased cognitive impairment and mortality risk, and will be defined as high anticholinergic burden in this study.
Measured: Baseline
Number of concurrent medications (polypharmacy status)
Total number of prescription, over-the-counter, and herbal medications; ≥5 defined as polypharmacy, ≥10 as excessive polypharmacy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Jun 2026
- Primary completion15 Jul 2026
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Falls (Accidents) in Old AgeStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gültekin KADI, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813143
- Sponsor's protocol ID
- GaziU - Geri
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding individual participant data (IPD) sharing has not yet been made. This is a single-center study conducted as part of a medical specialty thesis, and no data-sharing infrastructure or repository has been established at this stage. The investigators will determine a data-sharing plan prior to or at the time of results publication, taking into account patient confidentiality (including de-identification of ultrasound images) and institutional data protection requirements.
Publications
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.
PubMed 35054402Stewart 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.
PubMed 34104401Ozturk 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.
PubMed 35660496
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Fall Risk, Muscle Strength, and Anticholinergic Burden in Geriatric Patients Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT07813143
- Acronym / sponsor ID
- GaziU - Geri
- Conditions
- Falls (Accidents) in Old Age, Falls, Anticholinergics, Sarcopenia, Geriatric
- Keywords
- Falls, Sarcopenia, Geriatric, Anticholinergics burden
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Falls are a leading cause of morbidity, injury, and increased health care utilization among older adults presenting to the emergency department. Polypharmacy, high anticholinergic medication burden, and sarcopenia have each been independently associated with increased fall risk in older populations, but their combined and possibly synergistic effect in the acute emergency department setting has not been well characterized.
This is a single-center, prospective, cross-sectional observational study conducted at the Department of Emergency Medicine, Gazi University Faculty of Medicine. Patients aged 65 years or older presenting to the emergency department will be screened for eligibility. After initial evaluation by the treating physician, eligible patients will be informed about the study by a member of the research team, and those who provide written informed consent will be enrolled.
Exclusion criteria include: prior major upper or lower extremity surgery, prosthesis, or amputation that would prevent ultrasound or hand-grip measurement; acute bilateral femur or hip fracture; 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; and bedbound status or stroke sequelae preventing assessment.
Data collection. Using a study-specific case report form, the following will be recorded at the time of the emergency department visit: age, sex, number of comorbidities, fall history over the preceding 12 months, and prior hospitalization history. All medications currently used by the patient - prescription, over-the-counter, and herbal - will be documented. Concurrent use of 5 or more medications will be classified as polypharmacy, and 10 or more as excessive polypharmacy. Anticholinergic burden will be calculated using the Anticholinergic Burden Scale (ACB), with a total score of 3 or higher defined as high anticholinergic burden. Functional status and frailty will be assessed using the Clinical Frailty Scale (CFS) and the ECOG Performance Status scale.
Muscle assessment. Hand grip strength will be measured using a hand dynamometer, and patients will be classified as probable sarcopenia (+) or probable sarcopenia (-) based on this measurement. Quadriceps muscle thickness will be assessed by point-of-care ultrasound (GE Healthcare Venue Point of Care) using a linear probe, with the patient in the supine position. Measurements will be taken at the midpoint between the anterior superior iliac spine and the patella, on the anterior thigh. Rectus femoris (RF) and vastus intermedius (VI) thickness will be measured separately, and combined muscle thickness (CMT) - the distance between the subcutaneous fat layer and the femoral cortex - will be recorded in millimeters. Sarcopenia will be defined according to EWGSOP2 criteria.
Ultrasound measurements will be performed by two emergency medicine residents with prior basic ultrasound training, following a standardized 4-hour theoretical and hands-on training session delivered by an emergency medicine faculty member with 8 years of point-of-care ultrasound experience. A pilot phase involving 20 patients per trained resident will be used to confirm image quality and measurement adequacy before full enrollment begins. All ultrasound images will be stored and reviewed by emergency medicine faculty; measurements with inadequate image quality will be excluded from analysis, though other adequate-quality extremity data from the same patient will still be included.
Outcomes. The relationship between polypharmacy, anticholinergic burden, and sarcopenia parameters (muscle thickness and grip strength) and fall risk and clinical outcomes (major injury, hospital admission, emergency department length of stay, need for consultation) will be evaluated using multivariable statistical methods. No study-specific interventions, treatments, or additional laboratory tests will be performed; all assessments are one-time and use measurements already standard in routine clinical care. Findings will be reported in accordance with the STROBE guidelines for observational studies.
Based on a reported 12-month fall incidence of 37.2% among older adults in Turkey and expected annual enrollment volumes, a minimum sample size of 313 patients (157 male, 156 female) was calculated for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and older presenting to the Emergency Department of Gazi University Hospital, enrolled consecutively based on eligibility criteria.
Key inclusion criteria (3 listed)
- Age 65 years or older
- Presenting to the emergency department
- Willing and able to provide written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Fall History and Polypharmacy Status
Time frame: Baseline
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.
Association Between Fall History and Anticholinergic Burden
Time frame: Baseline
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.
Association Between Fall History and Probable Sarcopenia
Time frame: Baseline
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.
4 secondary outcomes
Hand-grip strength
Time frame: Baseline
Combined quadriceps muscle thickness (CMT)
Time frame: Baseline
Anticholinergic Burden Scale (ACB) score
Time frame: Baseline
Number of concurrent medications (polypharmacy status)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 35054402Wang 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.
- Background: PubMed 34104401Stewart 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.
- Background: PubMed 35660496Ozturk 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.
- Individual participant dataSharing planned: Undecided. A decision regarding individual participant data (IPD) sharing has not yet been made. This is a single-center study conducted as part of a medical specialty thesis, and no data-sharing infrastructure or repository has been established at this stage. The investigators will determine a data-sharing plan prior to or at the time of results publication, taking into account patient confidentiality (including de-identification of ultrasound images) and institutional data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Falls (Accidents) in Old Age and Falls, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Fall History and Polypharmacy Status (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813143, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.