Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 10:23 AM
Study NCT ID:
NCT06006494
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D005221', 'term': 'Fatigue'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Aerobic exercises, resistant exercises and yoga'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-28', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': '14 weeks', 'description': "It assesses the impact of fibromyalgia on the patient's health and functional abilities.\n\nHigh scores indicate that the disease affects the person more. The total score can be between 0-80. A score of 80 indicates high influence."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['women', 'sleep', 'tiredness'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '29291206', 'type': 'BACKGROUND', 'citation': 'Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20.'}, {'pmid': '21725900', 'type': 'BACKGROUND', 'citation': 'Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2.'}, {'pmid': '28636204', 'type': 'BACKGROUND', 'citation': 'Bidonde J, Busch AJ, Schachter CL, Overend TJ, Kim SY, Goes SM, Boden C, Foulds HJ. Aerobic exercise training for adults with fibromyalgia. Cochrane Database Syst Rev. 2017 Jun 21;6(6):CD012700. doi: 10.1002/14651858.CD012700.'}, {'pmid': '24362925', 'type': 'BACKGROUND', 'citation': 'Busch AJ, Webber SC, Richards RS, Bidonde J, Schachter CL, Schafer LA, Danyliw A, Sawant A, Dal Bello-Haas V, Rader T, Overend TJ. Resistance exercise training for fibromyalgia. Cochrane Database Syst Rev. 2013 Dec 20;2013(12):CD010884. doi: 10.1002/14651858.CD010884.'}, {'pmid': '32110633', 'type': 'BACKGROUND', 'citation': 'Verma A, Shete SU, Doddoli G. Yoga therapy for fibromyalgia syndrome: A case report. J Family Med Prim Care. 2020 Jan 28;9(1):435-438. doi: 10.4103/jfmpc.jfmpc_816_19. eCollection 2020 Jan.'}, {'pmid': '39946182', 'type': 'DERIVED', 'citation': 'Sevgin O, Bugday B, Aydogan Baykara R, Gunendi G, Akkurt B, Atasoy H, Dikmen Hosbas B, Akkurt MF, Karamancioglu B. Efficacy of different exercises in women with fibromyalgia syndrome: a randomised controlled trial. Clin Exp Rheumatol. 2025 Jun;43(6):1010-1018. doi: 10.55563/clinexprheumatol/uol8so. Epub 2025 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'In this study, yoga, aerobic exercise, resistance exercise training in female individuals with fibromyalgia syndrome; It was aimed to compare their effectiveness on fatigue, quality of life and pain.', 'detailedDescription': 'The study was planned as a randomized controlled study. Participants will be divided into 3 groups by simple randomization method. groups will be named as aerobic, yoga and resistance exercise groups. 12-week exercise protocols will be applied to all participants. Participants before and after treatment; The Fibromyalgia Impact Questionnaire, the McGill Pain Questionnaire for pain assessment, the Chalder Fatigue Scale to assess their fatigue level, will be filled in by the participants before and after the study. The data obtained will be statistically analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-45\n* Be woman\n* Being diagnosed with fibromyalgia\n\nExclusion Criteria:\n\n* Receiving pharmacological treatment\n* Having had a surgical operation in the last 6 months\n* Being pregnant\n* Having a musculoskeletal injury'}, 'identificationModule': {'nctId': 'NCT06006494', 'briefTitle': 'Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': 'Uskudar53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aerobic group', 'description': 'only a separate aerobic exercise will be given', 'interventionNames': ['Other: aerobic']}, {'type': 'EXPERIMENTAL', 'label': 'resistant group', 'description': 'aerobic and resistance exercises will be given', 'interventionNames': ['Other: aerobic', 'Other: resistant']}, {'type': 'EXPERIMENTAL', 'label': 'yoga group', 'description': 'aerobic exercises will be given and yoga will be done', 'interventionNames': ['Other: aerobic', 'Other: yoga']}], 'interventions': [{'name': 'aerobic', 'type': 'OTHER', 'description': 'We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; includes activities such as walking, cycling, jogging, aerobic dancing, swimming.\n\nAn average of 50 minutes of exercise per day will be required, 3 days a week.', 'armGroupLabels': ['aerobic group', 'resistant group', 'yoga group']}, {'name': 'resistant', 'type': 'OTHER', 'description': 'Resistance exercises are the whole of the exercises in which effort is made against the weight and the weight is lifted. Exercises with therabands, dumbbells or body weight will be given. The exercises will be done 2 days a week for an average of 30-40 minutes.', 'armGroupLabels': ['resistant group']}, {'name': 'yoga', 'type': 'OTHER', 'description': 'Yoga is basically breathing exercises, warm-up exercises, relaxation, It is a session consisting of movements and relaxation exercises.movements are performed by standing in a fixed posture for 15 seconds to 2 minutes in a certain posture, they are postures for both strengthening, stretching and balance. Yoga practice will be done 2 days a week for an average of 40 minutes.', 'armGroupLabels': ['yoga group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Uskudar University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Hilal ATASOY', 'role': 'STUDY_CHAIR', 'affiliation': 'Uskudar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst.Prof.Dr.', 'investigatorFullName': 'Dr. Öğr. Üyesi Ömer Şevgin', 'investigatorAffiliation': 'Uskudar University'}}}}