Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-30 @ 3:00 AM
Study NCT ID:
NCT04706650
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Capacity, Cardiovascular Risk Factors and Disease-related Variables in Axial Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}], 'ancestors': [{'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_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-10', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-10', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean difference in exercise capacity of axSpA patients and controls', 'timeFrame': 'may- october 2014', 'description': 'maximal METs achieved by a maximal treadmill test by Bruce protocol'}], 'secondaryOutcomes': [{'measure': 'Mean difference in heart rate recovery of axSpA patients and controls', 'timeFrame': 'may- october 2014', 'description': 'peak heart rate achieved by maximal exercise minus heart rate at 1st minute of recovery phase'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['axial spondyloarthritis', 'exercise capacity', 'cardiovascular risk factors', 'nonradiographic axial spondyloarthritis', 'cardiorespiratory fitness'], 'conditions': ['Exercise Capacity', 'Axial Spondyloarthritis']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to study the associations between exercise capacity and cardiovascular (CV) risk factors in axial spondyloarthritis (axSpA) patients and to determine possible relationships with disease-related variables. Thirty eight patients and 38 controls were recruited in our cross-sectional controlled study. Comprehensive systemic and musculoskeletal examinations were carried out in both of the groups. Cardiovascular risk profile data, ASDAS-CRP, 10-year CV event risk, physical activity levels (IPAQ) were recorded. A maximal treadmill exercise test by Bruce protocol was administered to all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Thirty eight patients fulfilling the ASAS axial SpA criteria were recruited from the department of Gazi University Physical Medicine and Rehabilitation Rheumatology. 38 control subjects were randomly recruited from local hospital staff with a similar range of sex and age to the patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of axial SpA\n* must be able to walk\n\nExclusion Criteria:\n\n* established cardiac disease including structural heart diseases,\n* uncontrolled hypertension,\n* cardiac rhythm disorder,\n* unstable angina pectoris,\n* chronical renal and/or hepatic disease,\n* malignancy,\n* neuromuscular disease\n* musculoskeletal deformity\n* the history of an inflammatory arthritis for control group'}, 'identificationModule': {'nctId': 'NCT04706650', 'briefTitle': 'Exercise Capacity, Cardiovascular Risk Factors and Disease-related Variables in Axial Spondyloarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'Exercise Capacity in Axial Spondyloarthritis and Factors Affecting it: a Cross-sectional Controlled Study', 'orgStudyIdInfo': {'id': 'muğla sıtkı koçman university'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist medical doctor', 'investigatorFullName': 'Ebru Koseoglu Tohma', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}