Frailty Status and Increased Risk for Falls

Recruiting

• Conditions: Frailty; Fall; Anticholinergic Toxicity
• Interventions: Diagnostic Test: Fall assessment

• Registration Number: NCT04233541
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

We hypothesized that the use of anticholinergic medications may precipitate falls differently by frailty status in older adults. Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic prospectively enter into the study. Frailty status is defined according to the Physical Frailty Phenotype. The drugs are categorized according to the ACB scale

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 Timeline

• Study Start: 2017-05-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Last Update Submitted: 2020-01-15
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-01-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-fallers	Fall assessment	Participants with no fall history consist the group of ''non-fallers''
Fallers	Fall assessment	Participants who reported one or more falls within the 12 months preceding the study consist the group of ''fallers''.

Primary Outcome Measures

Name	Time	Method
Fall assessment	1-2 hours	We will assess the association between anticholinergic burden (ACB) and falls based on frailty status among older adults.

Trial Locations

Locations (1)

Gulhane Faculty of Medicine & Gulhane Training and Research Hospital; 🇹🇷 Ankara, Turkey