MedPath

Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation

Completed
Conditions
Atrial Fibrillation
Registration Number
NCT04754360
Lead Sponsor
Izmir Bakircay University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
125
Inclusion Criteria
  • Diagnosis of paroxysmal, persistant or permanent atrial fibrillation
Exclusion Criteria
  • Diagnosis of heart failure or any chronic respiratory disease
  • Recent coronary bypass surgery
  • Previous heart valve surgery
  • Rheumatic valvular heart disease
  • Recent acute myocardial infarction
  • Having a pacemaker

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The European Heart Rhythm Association (EHRA) scoreAt baseline

Functional impairment and symptom burden of the patients will be determined according to The European Heart Rhythm Association (EHRA) score. While EHRA class 1 indicates asymptomatic patients, EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment, respectively.

6-min walk distanceAt baseline

Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).

Number of repetitions in 30-second sit-to-stand testAt baseline

Participants will be asked to perform sit-to-stand maneuver as fast as possible for 30 seconds and the number of completed repetitions will be recorded.

Secondary Outcome Measures
NameTimeMethod
Maximum inspiratory pressure (MIP)At baseline

MIP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)

International Physical Activity Questionnaire - Short FormAt baseline

International Physical Activity Questionnaire - Short Form will be used to measure physical activity level

Maximum expiratory pressure (MEP)At baseline

MEP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)

Forced Vital Capacity (FVC)At baseline

FVC will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)

Forced Expiratory Volume in 1 second (FEV1)At baseline

FEV1 will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)

Peak Expiratory Flow (PEF)At baseline

PEF will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)

Short Form-36At baseline

Short Form-36 questionnaire will be used to measure quality of life.

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa, Institute of Cardiology

🇹🇷

Istanbul, Turkey

Istanbul University-Cerrahpasa, Institute of Cardiology
🇹🇷Istanbul, Turkey

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.