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.

Study Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study Start: 2021-02-15
• Study First Posted: 2021-02-15
• Primary Completion: 2021-05-10
• Study Completion: 2021-05-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-10
• Last Update Posted: 2021-10-19

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

Name	Time	Method
The European Heart Rhythm Association (EHRA) score	At 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 distance	At 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 test	At 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

Name	Time	Method
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 Form	At 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-36	At 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