Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-28 @ 1:06 AM
Study NCT ID:
NCT06739369
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Arterial Stiffness and Pulmonary and Extrapulmonary Features in Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial stiffness', 'timeFrame': '1st day', 'description': 'It will be evaluated with brachial pulse waves.'}, {'measure': 'Respiratory muscle strength', 'timeFrame': '1st day', 'description': 'Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using a portable mouth pressure device.'}, {'measure': 'Respiratory muscle endurance', 'timeFrame': '1st day', 'description': 'This will be evaluated with increased workload testing.'}, {'measure': 'Exercise capacity', 'timeFrame': '1st day', 'description': 'Exercise capacity will be assessed with 6 minute walk test.'}, {'measure': 'Peripheral muscle strength', 'timeFrame': '1st day', 'description': 'Hand grip strength will be assessed with a grip dynamometer.'}, {'measure': 'Muscle function', 'timeFrame': '1st day', 'description': 'It will be evaluated with one-minute sit to stand test'}], 'secondaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': '1st day', 'description': 'Physical activity level will be evaluated using International Physical Activity Questionnaire-Short form'}, {'measure': 'Forced vital capacity', 'timeFrame': '1st day', 'description': 'Forced vital capacity (FVC) will be assessed using spirometry.'}, {'measure': 'Forced expiratory volume in one second', 'timeFrame': '1st day', 'description': 'Forced expiratory volume in one second (FEV1) will be assessed using spirometry.'}, {'measure': 'Forced expiratory volume in one second/forced vital capacity ratio', 'timeFrame': '1st day', 'description': 'Forced expiratory volume in one second/forced vital capacity ratio will be assessed using spirometry.'}, {'measure': 'Peak expiratory flow', 'timeFrame': '1st day', 'description': 'Peak expiratory flow (PEF) will be assessed using spirometry.'}, {'measure': 'Forced mid-expiratory flow', 'timeFrame': '1st day', 'description': 'Forced mid-expiratory flow (FEF25-75) will be assessed using spirometry.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis (AS)']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the relationship between arterial stiffness and pulmonary and extrapulmonary features in patients with ankylosing spondylitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed up with a diagnosis of ankylosing spondylitis will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ankylosing spondylitis according to ASAS diagnostic criteria\n* Being aged 18-65\n* Stable medication use for at least 3 months\n* Voluntary participation in the study\n\nExclusion Criteria:\n\n* Having uncontrolled cardiopulmonary disease\n* Being pregnant\n* Having undergone recent surgery\n* Presence of malignancy\n* Failure to perform to assessments'}, 'identificationModule': {'nctId': 'NCT06739369', 'briefTitle': 'The Relationship Between Arterial Stiffness and Pulmonary and Extrapulmonary Features in Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'Investigation of the Relationship Between Arterial Stiffness and Pulmonary and Extrapulmonary Features in Patients With Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': '2024-14/120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ankylosing spondylitis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Firat', 'role': 'CONTACT', 'email': 'mervefirat@ahievran.edu.tr', 'phone': '+90 850 441 02 44'}], 'facility': 'Kirsehir Ahi Evran University', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}], 'centralContacts': [{'name': 'Merve Firat', 'role': 'CONTACT', 'email': 'mervefirat@ahievran.edu.tr', 'phone': '+90 850 441 02 44'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Merve Firat', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}