- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03420326
The Relationship Between Atrial Fibrillation and Frailty in Community-Dwelling Elderly
March 3, 2019 updated by: National Taiwan University Hospital
The Relationship Between Atrial Fibrillation and Frailty in Community-Dwelling
Atrial fibrillation (AF) is the most common arrhythmias in clinical practice.
Research investigating hospitalized patients have indicated there are deleterious effects of AF on patients besides the disease burden itself, including longer stay days for hospitalization, higher rates of frailty and increasing mortality rate after discharged in six months.
In the community-dwelling research also found that elderly with AF have lower cognitive function, physical functional tests score and slower walking speed compared with the health ones.
However, there is limited articles investigating the impact of AF on community-dwelling elderly, and the relationship between AF and frailty is also lack of discussion.
According to the aged society and increasing prevalence of AF, the relationship between AF and frailty in community-dwelling elderly is warranting investigated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
256
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhongzheng District
-
Taipei, Zhongzheng District, Taiwan, 100
- Ming-Ting Yang
-
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
National Taiwan University Hospital Communities in Taipei city
Description
Inclusion Criteria:
- Older than 65 years old
Exclusion Criteria:
diagnosed with the following disease
- Cardiovascular diseases: myocardial infarction, peripheral vascular diseases, aortic plaque
- Cerebrovascular disease: stroke, transient ischemic attack, emboli
- Heart failure
- Participants who cannot finish the trial
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
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Atria fibrillation (AF) group
|
The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status
|
Non-AF group
|
The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frailty status
Time Frame: The frail status assessment would take about 10 minutes
|
Edmonton frail scale and Frailty criteria by Dr. Fried would be used to evaluate the frail status of the participants
|
The frail status assessment would take about 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: The body composition test would take about 10 minutes
|
Maltron BioScan BF-920, Essex, UK would be used to assess participants' body composition
|
The body composition test would take about 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Meng-Yueh Chien, college of Medicine, National Taiwan University
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 (Actual)
January 26, 2018
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
January 25, 2018
First Submitted That Met QC Criteria
January 28, 2018
First Posted (Actual)
February 5, 2018
Study Record Updates
Last Update Posted (Actual)
March 5, 2019
Last Update Submitted That Met QC Criteria
March 3, 2019
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201711083RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Atrial Fibrillation
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Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
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AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
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Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
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Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
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Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
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R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Frailty status assessment
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National Taiwan University HospitalRecruitingCommunity-dwelling ElderlyTaiwan
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German Heart InstituteThe German Heart FoundationUnknown
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University of GlasgowRecruitingFrail Elderly Syndrome | Frailty | SurgeryUnited Kingdom
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University Health Network, TorontoCompleted
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University Hospital, Clermont-FerrandRecruiting
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South Tees Hospitals NHS Foundation TrustUnknownVascular DiseasesUnited Kingdom
-
University of GiessenRecruiting
-
Royal Brompton & Harefield NHS Foundation TrustBurdett Trust for NursingTerminated
-
Mayo ClinicCompletedHeart FailureUnited States
-
Princess Alexandra Hospital, Brisbane, AustraliaRecruitingGastrointestinal DiseasesAustralia