Frailty Status and Increased Risk for Falls

Frailty Clinical Trial

Official title:

Frailty Status and Increased Risk for Falls: The Role of Anticholinergic Burden

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233541
• Other study ID #: 2016/1648-463
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2020
• Source: Saglik Bilimleri Universitesi
• Contact: Mehmet I Naharci, Assoc.Prof.
• Phone: 905445120147
• Email: drnaharci[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticholinergic Toxicity
• Fall
• Frailty

Intervention

Diagnostic Test:
• Fall assessment
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.

Locations

Country	Name	City	State
Turkey	Gulhane Faculty of Medicine & Gulhane Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall assessment	We will assess the association between anticholinergic burden (ACB) and falls based on frailty status among older adults.	1-2 hours