Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT04754360
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2021-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-10', 'studyFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The European Heart Rhythm Association (EHRA) score', 'timeFrame': 'At baseline', 'description': '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.'}, {'measure': '6-min walk distance', 'timeFrame': 'At baseline', 'description': 'Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).'}, {'measure': 'Number of repetitions in 30-second sit-to-stand test', 'timeFrame': 'At baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': 'At baseline', 'description': 'FVC will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)'}, {'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': 'At baseline', 'description': 'FEV1 will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)'}, {'measure': 'Peak Expiratory Flow (PEF)', 'timeFrame': 'At baseline', 'description': 'PEF will be measured using basic spirometry according to the guideline of European Respiratory Society (ERS)'}, {'measure': 'Maximum inspiratory pressure (MIP)', 'timeFrame': 'At baseline', 'description': 'MIP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)'}, {'measure': 'Maximum expiratory pressure (MEP)', 'timeFrame': 'At baseline', 'description': 'MEP will be measured using electronic mouth pressure meter according to the guideline of European Respiratory Society (ERS)'}, {'measure': 'Short Form-36', 'timeFrame': 'At baseline', 'description': 'Short Form-36 questionnaire will be used to measure quality of life.'}, {'measure': 'International Physical Activity Questionnaire - Short Form', 'timeFrame': 'At baseline', 'description': 'International Physical Activity Questionnaire - Short Form will be used to measure physical activity level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Symptomatology', 'Functional impairment', 'Exercise capacity', '6-min walk test', 'Sit-to-stand test', 'Cut-off value'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed with atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Diagnosis of paroxysmal, persistant or permanent atrial fibrillation\n\nExclusion Criteria:\n\n* Diagnosis of heart failure or any chronic respiratory disease\n* Recent coronary bypass surgery\n* Previous heart valve surgery\n* Rheumatic valvular heart disease\n* Recent acute myocardial infarction\n* Having a pacemaker'}, 'identificationModule': {'nctId': 'NCT04754360', 'briefTitle': 'Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Bakircay University'}, 'officialTitle': 'Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'bakircaymzeren01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial fibrillation', 'description': 'Adult patients with atrial fibrillation', 'interventionNames': ['Other: Evaluation of functional impairment', 'Other: Evaluation of pulmonary function', 'Other: Evaluation of quality of life', 'Other: Evaluation of physical activity level']}], 'interventions': [{'name': 'Evaluation of functional impairment', 'type': 'OTHER', 'description': 'Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test', 'armGroupLabels': ['Atrial fibrillation']}, {'name': 'Evaluation of pulmonary function', 'type': 'OTHER', 'description': 'Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.', 'armGroupLabels': ['Atrial fibrillation']}, {'name': 'Evaluation of quality of life', 'type': 'OTHER', 'description': 'Quality of life will be evaluated using Short Form-36 Questionnaire.', 'armGroupLabels': ['Atrial fibrillation']}, {'name': 'Evaluation of physical activity level', 'type': 'OTHER', 'description': 'Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form', 'armGroupLabels': ['Atrial fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa, Institute of Cardiology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Bakircay University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof. Dr.', 'investigatorFullName': 'Melih Zeren', 'investigatorAffiliation': 'Izmir Bakircay University'}}}}