Clinical trial NCT04754360: Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Symptomatology
Functional impairment
Exercise capacity
6-min walk test
Sit-to-stand test
Cut-off value
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2021-02-15
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with atrial fibrillation

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.

Eligibility criteria: 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

Primary outcomes:
measure: The European Heart Rhythm Association (EHRA) score
timeFrame: At baseline
measure: 6-min walk distance
timeFrame: At baseline
measure: Number of repetitions in 30-second sit-to-stand test
timeFrame: At baseline
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: At baseline
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: At baseline
measure: Peak Expiratory Flow (PEF)
timeFrame: At baseline
measure: Maximum inspiratory pressure (MIP)
timeFrame: At baseline
measure: Maximum expiratory pressure (MEP)
timeFrame: At baseline
measure: Short Form-36
timeFrame: At baseline
measure: International Physical Activity Questionnaire - Short Form
timeFrame: At baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa, Institute of Cardiology
Study officials:
References: