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

NCT ID: NCT05902676

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-15

Study Completion Date

2023-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Ataturk Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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hasan oztin

Head of Geriatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hasan Oztin, MD

Role: PRINCIPAL_INVESTIGATOR

Izmir Katip Celebi University, Ataturk Education And Research Hospital,

Central Contacts

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Hasan Oztin, MD

Role: CONTACT

+905053355623

References

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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.

Reference Type BACKGROUND
PMID: 21707557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15676035 (View on PubMed)

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.

Reference Type RESULT
PMID: 22178471 (View on PubMed)

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

Reference Type RESULT
PMID: 24278735 (View on PubMed)

Other Identifiers

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301-16/1648-946

Identifier Type: -

Identifier Source: org_study_id

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