Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT04754360
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2021-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 and/or 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:
False
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?: