Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT06678932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-07
First Post:
2024-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arm Exercise Capacity, Muscle Strength and Activities of Daily Living in Patients with Fibromyalgia Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper extremity exercise capacity', 'timeFrame': '1st day', 'description': 'This will be evaluated with arm ergometer test.'}, {'measure': 'Muscle strength', 'timeFrame': '1st day', 'description': 'Hand grip strength will be measured using a hand grip dynamometer.'}, {'measure': 'Muscle endurance', 'timeFrame': '1st day', 'description': '30 second push-up test will be used, and total number will be recorded.'}, {'measure': 'Activities of daily living', 'timeFrame': '1st day', 'description': 'It will be evaluated with the Glittre Activities of Daily Living test, and total time will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with fibromyalgia syndrome and healthy individuals will be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria-fibromyalgia syndrome:\n\n* Being diagnosed with fibromyalgia syndrome\n* Being aged 18-65\n* Stable use of medication for at least 3 months or longer\n* Volunteering to participate in the study\n\nExclusion Criteria-fibromyalgia syndrome:\n\n* Having comorbidities that may affect physical functions\n* Failure to cooperate with tests to be performed\n* Presence of exercise test contraindication\n\nInclusion Criteria-healthy control:\n\n* Being aged 18-65\n* Volunteering to participate in the study\n\nExclusion Criteria-healthy control:\n\n* Having a chronic or systemic disease\n* Failure to cooperate with tests to be performed'}, 'identificationModule': {'nctId': 'NCT06678932', 'briefTitle': 'Arm Exercise Capacity, Muscle Strength and Activities of Daily Living in Patients with Fibromyalgia Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'Comparison of Arm Exercise Capacity, Muscle Strength and Daily Living Activities of Patients with Fibromyalgia Syndrome and Healthy Controls', 'orgStudyIdInfo': {'id': '2024-13/115'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibromyalgia syndrome'}, {'label': 'Healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırşehir', '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'}], 'overallOfficials': [{'name': 'Basak Kavalci Kol', 'role': 'STUDY_CHAIR', 'affiliation': 'Kirsehir Ahi Evran University'}, {'name': 'Figen Tuncay', 'role': 'STUDY_CHAIR', 'affiliation': 'Kirsehir Ahi Evran University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Merve Firat', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}