Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-31 @ 5:13 AM
Study NCT ID:
NCT06554132
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Strength and Aerobic Capacity in Scleroderma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory muscle strength assessment', 'timeFrame': '5 minutes', 'description': 'Respiratory muscle strength will be assessed with an intraoral pressure gauge. These are the intraoral pressures measured at maximal respiration against a valve that closes the airways. When applying MIP, the patient is asked to perform maximal expiration. As a result, the patient is asked to maximally inspire against the closed airway and maintain this for 1-3 seconds. MEP, on the other hand, after maximal inspiration, the patient is asked to perform maximal expiration against the closed airway for 1-3 seconds.'}], 'secondaryOutcomes': [{'measure': 'Aerobic capacity assessment', 'timeFrame': '10 minutes', 'description': 'Aerobic capacity will be assessed using exercise testing. VO2max will be assessed using the Cosmed FitMate Pro® (Cosmed, Italy). The FitMate Pro® includes a turbine flowmeter to measure ventilation and a galvanic fuel cell oxygen sensor to analyze the oxygen fraction in expired gases.'}, {'measure': 'Fatigue assessment', 'timeFrame': '2 minutes', 'description': 'Fatigue will be assessed with the Fatigue Severity Scale (FSS), the Turkish validity and reliability of which was performed by Armutlu et al. This scale includes 9 questions related to fatigue.'}, {'measure': 'Pulmonary function test', 'timeFrame': '5 minutes', 'description': "Pulmonary function test is routinely performed in Ssk patients. FEV1, DLCO and FEV1/FVC values will be recorded from the patients' files."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scleroderma', 'Respiratory muscle strength', 'Aerobic capacity'], 'conditions': ['Scleroderma']}, 'descriptionModule': {'briefSummary': 'Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated', 'detailedDescription': 'Scleroderma is a systemic connective tissue disease characterized by progressive thickening of the skin, the etiology of which has not been fully elucidated, in which microvascular damage, immune activation and fibrosis play a role. Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. The study will include 15 patients and 15 healthy individuals of the same age and gender. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People who have not a chronic disease or othopedic disease will be included as Healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with Ssk according to ACR/EULAR criteria\n* Stable medical treatment for 3 months\n\nExclusion Criteria:\n\n* Having a regular exercise habit (doing regular exercise at least once a week for the last 3 months)\n* Comorbidity with another chronic disease that may affect aerobic capacity or respiratory muscle strength\n* Having concomitant acute respiratory diseases\n* Having a smoking habit\n* History of orthopedic or neurologic disease in the lower extremities that may prevent cycling'}, 'identificationModule': {'nctId': 'NCT06554132', 'briefTitle': 'Respiratory Muscle Strength and Aerobic Capacity in Scleroderma', 'organization': {'class': 'OTHER', 'fullName': 'Firat University'}, 'officialTitle': 'Investigation of Respiratory Muscle Strength and Aerobic Capacity in Patients With Scleroderma', 'orgStudyIdInfo': {'id': '2024/10-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Scleroderma group', 'description': 'Scleroderma patients will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.', 'interventionNames': ['Other: Scleroderma Group']}, {'label': 'Healthy group', 'description': 'Healthy people will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.', 'interventionNames': ['Other: Healthy group']}], 'interventions': [{'name': 'Scleroderma Group', 'type': 'OTHER', 'description': 'Scleroderma patients will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.', 'armGroupLabels': ['Scleroderma group']}, {'name': 'Healthy group', 'type': 'OTHER', 'description': 'Healthy people will be evaluated in terms of respiratory muscle strength, aerobic capacity, pulmonary function test and fatigue.', 'armGroupLabels': ['Healthy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23100', 'city': 'Elâzığ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Songul Baglan Yentur', 'role': 'CONTACT', 'email': 'songulbaglan23@hotmail.com', 'phone': '04242370000'}, {'name': 'Songul Baglan Yentur', 'role': 'CONTACT', 'email': 'songulbaglan23@hotmail.com', 'phone': '+904242370000'}], 'facility': 'Songul Baglan Yentur', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Firat University', 'investigatorFullName': 'Songül Bağlan Yentür', 'investigatorAffiliation': 'Firat University'}}}}