Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-01 @ 6:00 AM
Study NCT ID:
NCT05932433
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Sensory Test (QST), and', 'timeFrame': 'From enrollment to the end of the intervention at 6 weeks', 'description': 'Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.'}, {'measure': 'Psychological and PainTest', 'timeFrame': 'From enrollment to the end of the intervention at 6 weeks', 'description': 'Furthermore,Beck Depression Inventory and State-Trait Anxiety Inventory (STAI) will be perform as a psychological test. The Brief Pain Inventory (BPI) and a numerical rate scale will be perform as a pain tests.'}, {'measure': 'Descriptive parameters', 'timeFrame': 'From enrollment to the end of the intervention at 6 weeks', 'description': 'Descriptive parameters of the sample will be explain in a table'}], 'secondaryOutcomes': [{'measure': 'Interleukin analysis', 'timeFrame': 'From enrollment to the end of the intervention at 6 weeks', 'description': 'Interleukin-18 and interleukin-1β analysis will be perform in tha baseline in control group and at the end of the intervention in the experimental (exercise) group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis', 'Fibromyalgia', 'Arthritis Rheumatoid', 'Artrosis of the Knee', 'Chronic Pain', 'Central Sensitisation', 'Gut Microbiota', 'Exercise Therapy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality.\n\nThe intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up.\n\nThe participation will require:\n\n1. Attend the 12 therapeutic exercise sessions\n2. Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3).\n\nThe items to be evaluated will be the following:\n\n1. The Ronald Morris Disability Questionnaire (RMDQ)\n2. Anxiety (State-Trait Anxiety Inventory (STAI))\n3. Depression: Beck Depression Inventory (BDI)\n4. Quality of Life: SF-12\n5. Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI)\n6. Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM)\n7. Perform a pre blood test on interleukins IL-18 and IL-1β\n\nThis study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights.\n\nIn order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be at least 18 years old\n* Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia.\n\nExclusion Criteria:\n\n* Suffering or having suffered from cancer, psychiatric disorders, or another ongoing major illness (irritable bowel syndrome, hepatitis, Lyme disease or diabetes).\n* Patients will be excluded if they have more than 6 points on the Beck Depression Inventory, more than 30 points on the "State Trait Anxiety Inventory" or suffer from dementia.'}, 'identificationModule': {'nctId': 'NCT05932433', 'acronym': 'MiBioPain', 'briefTitle': 'Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.', 'orgStudyIdInfo': {'id': '1601202303523'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Exercise during 6 weeks, twice a week.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'There is no intervention'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Therapeutic exercise', 'physical activity'], 'description': 'Each session (45 minutes aprox) is made by: mobility, endurance and final exercise to rest. The sesion is going to perform twice a week during 6 weeks.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Rey Juan Carlos', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}], 'overallOfficials': [{'name': 'Jorge H Jorge Hugo Villafañe, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Responsable científico, Centro "S. Maria ai Colli" - Presidio Ospedaliero "Ausiliatrice", Torino, de la Fondazione Don Carlo Gnocchi Onlus, Italia.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Data and its interpretation are going to be publicated in the Scientific Community through specific and scientific Journals about this topic and Congress.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'María Elena González Álvarez', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}