The Effects Of Anticholinergic Burden On Daily Living Activities In Elderly Patients

NCT05902676 | Unknown

• 1 other identifier: 301-16/1648-946
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The anticholinergic burden was calculated based on the medications that the patients had used for more than 10 days. Short-term medications used by patients were not evaluated. Among all the medications used by the patients, those with anticholinergic effects were scored according to the scale, and the total anticholinergic burden was calculated by adding them up. Those who had no anticholinergic score were considered to have no anticholinergic burden. The study cohort will be stratified into two cohorts, distinguished by the presence or absence of anticholinergic burden. To evaluate the impact of anticholinergic burden on daily living activities and instrumental ADL, the groups will be compared with respect to hand grip strength and walking speed.In this study, the anticholinergic burden will be calculated based on medications used by the patients for more than 10 days, excluding short-term medications. Each medication with anticholinergic effects will be assigned a score according to a scale, and the total anticholinergic burden will be determined by summing up the scores. Patients without any anticholinergic score will be classified as having no anticholinergic burden. The study cohort will be divided into two groups based on the presence or absence of anticholinergic burden. To assess the impact of anticholinergic burden on daily living activities (ADLs) and instrumental ADLs, the groups will be compared in terms of hand grip strength and walking speed.

Conditions

Anticholinergic Syndrome; Anticholinergic Adverse Reaction; Antispasmodic Adverse Reaction; Antiarrhythmic Drug Adverse Reaction; Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use; Psychotropic Agents Causing Adverse Effects in Therapeutic Use

Keywords

anticholinergic burden; daily living activities; geriatrics

Outcome Measures

Primary Outcomes (1)

• The Barthel Index for Activities of Daily Living (ADL)

  ADL was evaluated on a scale of 100 points according to the patients' ability to feed themselves, bathe, perform personal hygiene, dress and undress, control bowel and bladder, use the toilet independently, use a wheelchair, mobility status, and ability to climb stairs.

  24 hours

Secondary Outcomes (3)

• The Lawton-Brody Instrumental Activities of Daily Living (IADL)

  24 hours

• Walking speed

  2 minute

• Hand grip strength

  1 minute

Study Arms (2)

no anticholinergic burden

Patients with a score of 0 were considered to have not used anticholinergic medications. Short-term use of medications, daily dosages of medications, and topical, ophthalmic, otologic, or inhalation medications were excluded from scoring.

anticholinergic burden

Patients with a score of 1 or higher were considered to have used anticholinergic medication. Short-term use of medications, daily dosages of medications, and topical, ophthalmic, otologic, or inhalation medications were excluded from scoring.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A prospective case-control study was designed, and 180 patients over 65 years of age who applied to the geriatrics outpatient clinic without a diagnosis of dementia and with a Mini-Mental State Examination (MMSE) score \>24 were included.

You may qualify if:

• Being over 65 years old
• Patients without a diagnosis of dementia and with MMSE\>24
• Patients who can communicate (without hearing or visual problems)
• Those who give written consent to participate in the study

You may not qualify if:

• Patients with a diagnosis of dementia at their initial visit,
• Bedridden patients (those with visual impairments)
• Patients with walking difficulties (due to pain, prostheses, visual problems, etc.), vitamin D deficiency (10) (20ng/dl\>) or those who use assistive devices (walker, cane, etc.) or those with sequelae of cerebrovascular events or hip fractures.
• Patients with a diagnosis of delirium,
• Those who underwent major surgery in the last 6 months,
• Those who experienced cardiac or cerebrovascular events during the follow-up period,
• Patients with infectious diseases,
• Those who did not sign or withdrew their consent form.

Sponsors & Collaborators

• Izmir Ataturk Training and Research Hospital: lead

Related Publications (4)

• Fox C, Richardson K, Maidment ID, Savva GM, Matthews FE, Smithard D, Coulton S, Katona C, Boustani MA, Brayne C. Anticholinergic medication use and cognitive impairment in the older population: the medical research council cognitive function and ageing study. J Am Geriatr Soc. 2011 Aug;59(8):1477-83. doi: 10.1111/j.1532-5415.2011.03491.x. Epub 2011 Jun 24.

  PMID: 21707557 BACKGROUND

• Lechevallier-Michel N, Molimard M, Dartigues JF, Fabrigoule C, Fourrier-Reglat A. Drugs with anticholinergic properties and cognitive performance in the elderly: results from the PAQUID Study. Br J Clin Pharmacol. 2005 Feb;59(2):143-51. doi: 10.1111/j.1365-2125.2004.02232.x.

  PMID: 15676035 BACKGROUND

• Prasad S, Sung B, Aggarwal BB. Age-associated chronic diseases require age-old medicine: role of chronic inflammation. Prev Med. 2012 May;54 Suppl(Suppl):S29-37. doi: 10.1016/j.ypmed.2011.11.011. Epub 2011 Dec 9.

  PMID: 22178471 RESULT

• Jansen PA, Brouwers JR. Clinical pharmacology in old persons. Scientifica (Cairo). 2012;2012:723678. doi: 10.6064/2012/723678. Epub 2012 Jul 28.

  PMID: 24278735 RESULT

MeSH Terms

Conditions

Anticholinergic Syndrome

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Hasan Oztin, MD

  Izmir Katip Celebi University, Ataturk Education And Research Hospital,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Oztin, MD

CONTACT

+905053355623; dr.hasanoztin@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Geriatrics

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 15, 2023
• Study Start: June 15, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06