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

Anticholinergic Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05902676
• Other study ID #: 301-16/1648-946
• Status: Not yet recruiting
• Start date: June 15, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: June 2023
• Source: Izmir Ataturk Training and Research Hospital
• Contact: Hasan Oztin, MD
• Phone: +905053355623
• Email: dr.hasanoztin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anticholinergic Adverse Reaction
• Anticholinergic Syndrome
• Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use
• Drug-Related Side Effects and Adverse Reactions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Ataturk Training and Research Hospital

References & 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Lawton-Brody Instrumental Activities of Daily Living (IADL)	IADL consisted of eight sections, including the ability to use a telephone, shop, prepare meals, clean the house, do laundry, take medication, travel, and manage finances, and was evaluated on a scale of 17 points. Low scores were considered an indicator of dependence.	24 hours
Secondary	Walking speed	For walking speed, the time to walk a 4.5-meter distance was measured.	2 minute
Secondary	Hand grip strength	Hand grip strength of the dominant hand was measured twice with a Jamar dynamometer while sitting with the elbow flexed at 90 degrees, and the highest value was recorded	1 minute