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

NCT ID: NCT04754360

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-05-10

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Atrial fibrillation

Adult patients with atrial fibrillation

Evaluation of functional impairment

Intervention Type OTHER

Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test

Evaluation of pulmonary function

Intervention Type OTHER

Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.

Evaluation of quality of life

Intervention Type OTHER

Quality of life will be evaluated using Short Form-36 Questionnaire.

Evaluation of physical activity level

Intervention Type OTHER

Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form

Interventions

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Evaluation of functional impairment

Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test

Intervention Type OTHER

Evaluation of pulmonary function

Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.

Intervention Type OTHER

Evaluation of quality of life

Quality of life will be evaluated using Short Form-36 Questionnaire.

Intervention Type OTHER

Evaluation of physical activity level

Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Izmir Bakircay University

OTHER

Sponsor Role lead

Responsible Party

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Melih Zeren

Assist. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University-Cerrahpasa, Institute of Cardiology

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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bakircaymzeren01

Identifier Type: -

Identifier Source: org_study_id