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

June 13, 2023 updated by: hasan oztin, Izmir Ataturk Training and Research Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Barthel Index for Activities of Daily Living (ADL)
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Lawton-Brody Instrumental Activities of Daily Living (IADL)
Time Frame: 24 hours
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
Walking speed
Time Frame: 2 minute
For walking speed, the time to walk a 4.5-meter distance was measured.
2 minute
Hand grip strength
Time Frame: 1 minute
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Ataturk Training and Research Hospital

Investigators

  • Principal Investigator: Hasan Oztin, MD, Izmir Katip Celebi University, Ataturk Education And Research Hospital,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2023

Primary Completion (Estimated)

July 30, 2023

Study Completion (Estimated)

July 30, 2023

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301-16/1648-946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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