Clinical trial NCT05902676: The Effects Of Anticholinergic Burden On Daily Living Activities In Elderly Patients
Official title: The Effects Of Anticholinergic Burden On Daily Living Activities In Elderly Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Izmir Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Barthel Index for Activities of Daily Living (ADL)
timeFrame: 24 hours
Secondary outcomes:
measure: The Lawton-Brody Instrumental Activities of Daily Living (IADL)
timeFrame: 24 hours
measure: Walking speed
timeFrame: 2 minute
measure: Hand grip strength
timeFrame: 1 minute
Other outcomes:
Locations:
Study officials:
affiliation: Izmir Katip Celebi University, Ataturk Education And Research Hospital,
name: Hasan Oztin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Jansen PA, Brouwers JR. Clinical pharmacology in old persons. Scientifica (Cairo). 2012;2012:723678. doi: 10.6064/2012/723678. Epub 2012 Jul 28.