Viewing Study NCT04754360



Ignite Creation Date: 2024-05-06 @ 3:46 PM
Last Modification Date: 2024-10-26 @ 1:57 PM
Study NCT ID: NCT04754360
Status: COMPLETED
Last Update Posted: 2021-10-19
First Post: 2021-02-10

Brief Title: Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
Sponsor: Izmir Bakircay University
Organization: Izmir Bakircay University

Study Overview

Official Title: Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
Status: COMPLETED
Status Verified Date: 2021-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Cut-off values indicating higher symptom burden and impairment in health status in 6-min walk test and 30-second sit-to-stand test in patients with atrial fibrillation will be determined in the study
Detailed Description: The 6-min walk test 6MWT is the most used field test for measuring functional impairment in cardiopulmonary patients However to be able to objectively interpret 6MWT of a patient with specific chronic condition the distance walked in 6MWT should be compared to either a healthy control group or a cut-off value that was specifically determined for that population Such cut-off values are present for 6MWT in several cardiopulmonary diseases including COPD 350 m heart failure 200 m and pulmonary hypertension 400 m for identifying patients with high mortality poor prognosis andor poor health status but there is no cut-off value determined for atrial fibrillation AF The European Heart Rhythm Association EHRA score is a practical measure for assessing symptom burden and functional impairment caused by AF-related symptoms While EHRA class 1 indicates asymptomatic patients EHRA class 2 3 and 4 indicates higher severities of symptom burden and functional impairment Primary aim of this study is to determine a cut-off value in 6MWT for discriminating between the asymptomatic and symptomatic AF patients according to EHRA classification In addition a cut-off value for 30-second sit-to-stand test will be determined in these patients as well since sit-to-stand tests have gained a lot of interest in the recent literature for practically evaluating functional status in various cardiopulmonary conditions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None