Anticholinergic SyndromeNCT05902676
The Effects Of Anticholinergic Burden On Daily Living Activities In Elderly Patients
An observational study of Anticholinergic Syndrome and Anticholinergic Adverse Reaction, run by Izmir Ataturk Training and Research Hospital.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anticholinergic Syndrome, Anticholinergic Adverse Reaction, Antispasmodic Adverse Reaction
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Medical subject headings
- Anticholinergic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
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.
Measured: 24 hours
Walking speed
For walking speed, the time to walk a 4.5-meter distance was measured.
Measured: 2 minute
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
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anticholinergic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hasan oztin, Izmir Ataturk Training and Research Hospital
- Investigators
- Hasan Oztin, MD, Principal investigator, Izmir Katip Celebi University, Ataturk Education And Research Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902676
- Sponsor's protocol ID
- 301-16/1648-946
- Status last verified
- Jun 2023
- First submitted
- 22 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21707557Lechevallier-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.
PubMed 15676035Prasad 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.
PubMed 22178471Jansen PA, Brouwers JR. Clinical pharmacology in old persons. Scientifica (Cairo). 2012;2012:723678. doi: 10.6064/2012/723678. Epub 2012 Jul 28.
PubMed 24278735
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Anticholinergic Burden On Daily Living Activities In Elderly Patients
- ClinicalTrials.gov ID
- NCT05902676
- Acronym / sponsor ID
- 301-16/1648-946
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Izmir Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
The Lawton-Brody Instrumental Activities of Daily Living (IADL)
Time frame: 24 hours
Walking speed
Time frame: 2 minute
Hand grip strength
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 21707557Fox 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.
- Background: PubMed 15676035Lechevallier-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.
- Results publication: PubMed 22178471Prasad 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.
- Results publication: PubMed 24278735Jansen PA, Brouwers JR. Clinical pharmacology in old persons. Scientifica (Cairo). 2012;2012:723678. doi: 10.6064/2012/723678. Epub 2012 Jul 28.
- Individual participant dataSharing planned: Undecided
Related trials for Anticholinergic Syndrome
Not yet recruitingObservational study
Prevalence of Anticholinergics in Geriatric Patients With Acute Functional Deterioration
Frailty in Older Adults, Functional Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Oztin, MD principal investigator
Izmir Katip Celebi University, Ataturk Education And Research Hospital,
Questions about this trial
What is this clinical trial studying?
An observational study of Anticholinergic Syndrome and Anticholinergic Adverse Reaction, run by Izmir Ataturk Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hasan Oztin, MD (+905053355623, dr.hasanoztin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Barthel Index for Activities of Daily Living (ADL) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05902676, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.