Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-12 @ 2:40 PM
Study NCT ID:
NCT04817605
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Therapeutic Exercise in Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Baseline', 'description': 'VAS'}, {'measure': 'Pain intensity', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'VAS'}, {'measure': 'Quality of Sleep', 'timeFrame': 'Baseline', 'description': 'The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline'}, {'measure': 'Quality of Sleep', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline'}], 'secondaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': 'Baseline', 'description': 'The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline'}, {'measure': 'Pressure pain threshold', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment'}, {'measure': 'Central sensitization', 'timeFrame': 'Baseline', 'description': 'The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline'}, {'measure': 'Central sensitization', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS)'}, {'measure': 'Analysis of tryptophan metabolites', 'timeFrame': 'Baseline', 'description': 'The investigators measure the tryptophan metabolites with blood test analysis at baseline'}, {'measure': 'Analysis of tryptophan metabolites', 'timeFrame': 'through study completion, an average 10 weeks', 'description': 'The investigators measure the tryptophan metabolites with blood test analysis at baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Therapeutic Exercise', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.\n\nThe objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers.\n\nFor this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).\n\nPatients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks.\n\nThe variables are measured at the beginning and end of treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed medically with Fibromyalgia\n* Diagnosed according to the American College of Rheumatology criteria\n* Agreement to attend to treatment sessions\n\nExclusion Criteria:\n\n* Any kind of contraindications for physical activity\n* Other kind of diseases that could limit the intervention\n* Previous surgery last year\n* Medication modifications in the last 3 months'}, 'identificationModule': {'nctId': 'NCT04817605', 'briefTitle': 'Effects of Therapeutic Exercise in Patients With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Effects of Therapeutic Exercise in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'UVa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Therapy', 'interventionNames': ['Other: Therapeutic Exercise']}], 'interventions': [{'name': 'Therapeutic Exercise', 'type': 'OTHER', 'description': 'Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.', 'armGroupLabels': ['Exercise Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42004', 'city': 'Soria', 'country': 'Spain', 'facility': 'Sandra Jiménez Jiménez-del-Barrio', 'geoPoint': {'lat': 41.76401, 'lon': -2.46883}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Valladolid Faculty of Health Sciences', 'investigatorFullName': 'Sandra Jiménez', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}