- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04233541
Frailty Status and Increased Risk for Falls
Frailty Status and Increased Risk for Falls: The Role of Anticholinergic Burden
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Previous studies have found that the use of drugs with anticholinergic properties relate to increased prevalence of falls in older women and men. Frailty is associated with serious health outcomes including falls, hip fractures, and death. Frailty can be a relevant target to investigate its association with the risk of falls among the users of drugs with anticholinergic properties. A recent evidence suggests that the interaction between being frail and adverse outcomes in older adults receiving polypharmacy or centrally acting drugs is complex and not straightforward across all frailty phenotypes.
We classify the participants frail if they met at least three of five criteria, while those having one or two criteria were pre-frail, and others were non-frail. We determine the anticholinergic burden by using the Anticholinergic Cognitive Burden (ACB) Scale developed by Boustani et al.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mehmet I Naharci, Assoc.Prof.
- Phone Number: 905445120147
- Email: drnaharci@yahoo.com
Study Locations
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Ankara, Turkey, 06010
- Recruiting
- Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
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Contact:
- Mehmet I Naharci, Assoc.Prof.
- Phone Number: 905445120147
- Email: drnaharci@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Community-dwelling older adults
Exclusion Criteria:
- a history of dementia,
- current delirium or psychotic symptoms,
- taking antipsychotic medications,
- being functionally dependent to others,
- difficulty in communicating with the interviewer,
- terminal illness,
- being bedridden or wheelchair bound (≥2 weeks),
- difficulty in standing or walking,
- incomplete data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fallers
Participants who reported one or more falls within the 12 months preceding the study consist the group of ''fallers''.
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Through a comprehensive geriatric assessment carried out by our geriatrician led multidisciplinary team we gather information about fall recalls consistent with the definition of landing on the floor or ground.
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Non-fallers
Participants with no fall history consist the group of ''non-fallers''
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Through a comprehensive geriatric assessment carried out by our geriatrician led multidisciplinary team we gather information about fall recalls consistent with the definition of landing on the floor or ground.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fall assessment
Time Frame: 1-2 hours
|
We will assess the association between anticholinergic burden (ACB) and falls based on frailty status among older adults.
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1-2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ilker Tasci, Prof., Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/1648-463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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