Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-04 @ 10:45 PM
Study NCT ID:
NCT04650659
Status:
UNKNOWN
Last Update Posted:
2022-05-20
First Post:
2020-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Exercise Tests in Patients With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D030981', 'term': 'Acro-Osteolysis'}, {'id': 'D011928', 'term': 'Raynaud Disease'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010014', 'term': 'Osteolysis'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D000090122', 'term': 'Livedoid Vasculopathy'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020678', 'term': 'Microscopic Angioscopy'}], 'ancestors': [{'id': 'D000069416', 'term': 'Intravital Microscopy'}, {'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '1 mL arterial blood will be drawn from an arterial line before and after the 6MWT, respectively. In total 2 mL of arterial blood. Blood gas analysis will be performed.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine the validity of peripheral oxygen saturation measurement during 6-minute walk test in patients with Systemic Sclerosis.', 'timeFrame': '1 hour', 'description': 'The agreement between the peripheral oxygen saturation measured on the forehead, finger and earlobe and the arterial oxygen saturation from the blood gas analysis will be examined.'}], 'secondaryOutcomes': [{'measure': 'Examine the correlation between the 6-minute walk test, the 1-minute sit-to-stand test, and the 4-meter gait speed test in patients with Systemic Sclerosis.', 'timeFrame': '1 hour', 'description': 'The agreement between the 6-minute walk test, the 1-minute sit-to-stand test, and the 4-meter gait speed test in patients with Systemic Sclerosis.'}, {'measure': 'Investigate the correlation between functional exercise tests and the severity of pulmonary involvement in patients with Systemic Sclerosis.', 'timeFrame': '1 hour', 'description': 'The agreement between functional exercise tests and the severity of pulmonary involvement in patients with Systemic Sclerosis.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['6-Minute Walk Test', 'Scleroderma, Systemic', 'Oximetry', 'Exercise test', 'Raynaud Disease', 'HR-pQCT', 'Nailfold videocapillaroscopy'], 'conditions': ['Scleroderma, Systemic', 'Lung Diseases, Interstitial', 'Pulmonary Arterial Hypertension', 'Acroosteolysis']}, 'referencesModule': {'references': [{'pmid': '38340159', 'type': 'DERIVED', 'citation': 'Elkjaer AL, Naeser EU, Aaen KT, Hovgaard HL, Juhl-Olsen P, Bendstrup E, Sondergaard K. Validity and reliability of measurement of peripheral oxygen saturation during the 6-Minute Walk Test in patients with systemic sclerosis. Rheumatol Int. 2024 Apr;44(4):611-620. doi: 10.1007/s00296-024-05532-5. Epub 2024 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the validity of peripheral oxygen saturation measurement during the 6-minute walk test in patients with Systemic Sclerosis (SSc) and to examine the utility of two other functional tests as markers of pulmonary involvement in patients with SSc.', 'detailedDescription': 'Systemic Sclerosis (SSc) is a connective tissue disease characterized by progressive organ fibrosis and vascular dysfunction. The leading causes of disease related morbidity and mortality are interstitial lung disease (ILD) and pulmonary arterial hypertension (PAH). The 6-minute walk test (6MWT) is a submaximal functional exercise test used to evaluate ILD and PAH in patients with SSc. Desaturations during the 6MWT have been considered suggestive of ILD and PAH. Still, the optimal method to measure peripheral oxygen saturation during the 6MWT in patients with SSc remains unclear. Furthermore, other functional exercise tests may also be useful in patients with SSc.\n\nPatients with SSc will perform three functional exercise tests, and approximately half of the patients will be invited to repeat the tests 1 week later to determine test-retest reliability. Additionally, nailfold videocapillaroscopy (NVC) will be performed on every patient to assess the capillary density of the nailfold of the fingers. Furthermore, to study the effect of SSc on bone, a high resolution peripheral quantitative computed tomography (HRpQCT) scan of radius and distal interphalangeal joints (DIP)/distal phalanges will be performed.\n\nDuring the 6MWT, the peripheral oxygen saturation (SpO2) will be measured continuously on three anatomical locations. An arterial line will be placed, and blood will be drawn at baseline and after ended 6MWT and analysed for arterial oxygen saturation (SaO2). The correlation between the capillary density of the nailfold and the SpO2 measured on the finger will be assessed. The correlation between capillary density of the nailfold and bone status in the fingers and distal radius assessed with HRpQCT will be evaluated, and HRpQCT images will be compared with conventional radiography and DEXA. Bland-Altman plot will be used to display the agreement between SaO2 and SpO2 and between the two 6MWT. Further, the association between pulmonary variables and 6MWT results will be examined.\n\nTwo alternative functional exercise tests will be investigated and compared to results in the 6MWT: The 1-minute sit-to-stand test (1STST) and the 4-meter gait speed test (4MGS). The association between the three functional exercise tests and clinical parameters in patients with SSc will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are recruited if they have a clinical course at the Department of Rheumatology, Aarhus University Hospital (\\>500 patients with Scleroderma)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Systemic Sclerosis according to the ACR/EULAR 2013 criteria\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Overlap syndrome (except for rheumatoid arthritis and Sjögren syndrome)\n* Recent or ongoing lung infection\n* Other major comorbidities that could affect the functional exercise tests.\n* Pregnancy\n* Unable to understand the patient information'}, 'identificationModule': {'nctId': 'NCT04650659', 'briefTitle': 'Functional Exercise Tests in Patients With Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Measurement Properties and Performance of Functional Exercise Tests in Patients With Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'SSc6MWT2020'}, 'secondaryIdInfos': [{'id': '1-16-02-270-20', 'type': 'OTHER', 'domain': 'The Danish Data Protection Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Part one of the project', 'description': '83 patients with Systemic Sclerosis will perform three functional exercise tests on the same day. All 83 patients will be examined with NVC. Moreover, HRpQCT will be performed on all patients at baseline and after 1 year.', 'interventionNames': ['Diagnostic Test: 6-minute walk test part one', 'Diagnostic Test: 1-minute sit-to-stand test', 'Diagnostic Test: 4-meters gait speed test', 'Diagnostic Test: Nailfold videocapillaroscopy', 'Diagnostic Test: HR-pQCT', 'Diagnostic Test: Hand x-ray', 'Diagnostic Test: DEXA']}, {'label': 'Part two of the project', 'description': 'Half of the patients from part one of the project will be invited to repeat the three functional exercise tests approximately one week later in reverse order to determine test-retest reliability.', 'interventionNames': ['Diagnostic Test: 6-minute walk test part two', 'Diagnostic Test: 1-minute sit-to-stand test', 'Diagnostic Test: 4-meters gait speed test']}], 'interventions': [{'name': '6-minute walk test part one', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of: 6-minute walk distance, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured continuously on three anatomical location: the forehead, an earlobe and a finger. In patients who will accept an arterial line will be placed and blood gas will be analyzed.', 'armGroupLabels': ['Part one of the project']}, {'name': '6-minute walk test part two', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of: 6-minute walk distance, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured continuously on three anatomical location: the forehead, an earlobe and a finger. No arterial line will be placed.', 'armGroupLabels': ['Part two of the project']}, {'name': '1-minute sit-to-stand test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of: Number of repetitions, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured on the three anatomical locations mentioned above.', 'armGroupLabels': ['Part one of the project', 'Part two of the project']}, {'name': '4-meters gait speed test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of: Time to complete the 4 meters course and calculation of the 4-meters-gait-speed.', 'armGroupLabels': ['Part one of the project', 'Part two of the project']}, {'name': 'Nailfold videocapillaroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Capillary density measurement of: The finger with the probe and the average of all the fingers.\n\nNVC with 200 x magnification will be performed on the 2nd to 5th finger on both hands.', 'armGroupLabels': ['Part one of the project']}, {'name': 'HR-pQCT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging: One arm is scanned in a 9 mm-long volume of the distal radius (110 slices), and the distal part of the 2nd to 5th finger on both hands are scanned in a 36,08 mm-long volume (440 slices) at baseline and after 1 year.', 'armGroupLabels': ['Part one of the project']}, {'name': 'Hand x-ray', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging: Hand x-ray was performed on patients scanned with HR-pQCT, unless images were already available (≤ 1 year).', 'armGroupLabels': ['Part one of the project']}, {'name': 'DEXA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging: A bone density (DEXA) scan was performed on patients scanned with HR-pQCT, unless it was already available (≤ 2 years).', 'armGroupLabels': ['Part one of the project']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'The Department of Rheumatology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Klaus Søndergaard, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Rheumatology, Aarhus University Hospital, DK'}, {'name': 'Amanda Lynggaard Riis, Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rheumatology, Aarhus University Hospital, DK'}, {'name': 'Esben Uggerby Næser, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Rheumatology, Aarhus University Hospital, DK'}, {'name': 'Katja Thorup Aaen, Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rheumatology, Aarhus University Hospital, DK'}, {'name': 'Ellen-Margrethe Hauge, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Rheumatology, Aarhus University Hospital, DK'}, {'name': 'Frederik Cosedis Enevoldsen, Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Rheumatology, Aarhus University Hospital, DK'}, {'name': 'Rasmus Klose Jensen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Rheumatology, Aarhus University Hospital, DK'}, {'name': 'Josephine Therkildsen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Rheumatology, Aarhus University Hospital, DK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}