An observational study in Atrial Fibrillation, sponsored by Izmir Bakircay University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Izmir Bakircay University · Observational
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.
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.
3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.
This study's enrollment of 125 is below the median of 300 across 1,364 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Izmir Bakircay University is the lead sponsor of 73 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients diagnosed with atrial fibrillation
Exclusion Criteria:
Adult patients with atrial fibrillation
Other: Evaluation of functional impairment · Other: Evaluation of pulmonary function · Other: Evaluation of quality of life · Other: Evaluation of physical activity level
Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test
Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.
Quality of life will be evaluated using Short Form-36 Questionnaire.
Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form
The European Heart Rhythm Association (EHRA) score
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.
Time frame: At baseline
6-min walk distance
Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).
Time frame: At baseline
Number of repetitions in 30-second sit-to-stand test
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.
Time frame: At baseline
Forced Vital Capacity (FVC)
FVC will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)
Time frame: At baseline
Forced Expiratory Volume in 1 second (FEV1)
FEV1 will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)
Time frame: At baseline
Peak Expiratory Flow (PEF)
PEF will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)
Time frame: At baseline
Maximum inspiratory pressure (MIP)
MIP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)
Time frame: At baseline
Maximum expiratory pressure (MEP)
MEP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)
Time frame: At baseline
Short Form-36
Short Form-36 questionnaire will be used to measure quality of life.
Time frame: At baseline
International Physical Activity Questionnaire - Short Form
International Physical Activity Questionnaire - Short Form will be used to measure physical activity level
Time frame: At baseline
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Izmir Bakircay University