Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04220567
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2020-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Exercise and Patient-centred Education on Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-06', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Baseline', 'description': 'Measured using the Numeric Pain Rating Scale, NPS, 0-10'}, {'measure': 'Pain intensity', 'timeFrame': '4 weeks', 'description': 'Measured using the Numeric Pain Rating Scale, NPS, 0-10'}, {'measure': 'Pain intensity', 'timeFrame': '8 weeks', 'description': 'Measured using the Numeric Pain Rating Scale, NPS, 0-10'}, {'measure': 'Pain intensity', 'timeFrame': 'Follow-up 3 months', 'description': 'Measured using the Numeric Pain Rating Scale, NPS, 0-10'}, {'measure': 'Disability and Impact of Fibromyalgia', 'timeFrame': 'Baseline', 'description': 'Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100'}, {'measure': 'Disability and Impact of Fibromyalgia', 'timeFrame': '4 weeks', 'description': 'Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100'}, {'measure': 'Disability and Impact of Fibromyalgia', 'timeFrame': '8 weeks', 'description': 'Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100'}, {'measure': 'Disability and Impact of Fibromyalgia', 'timeFrame': 'Follow-up 3 months', 'description': 'Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100'}], 'secondaryOutcomes': [{'measure': 'Neuropathic components in pain', 'timeFrame': 'Baseline', 'description': 'Measured using the painDETECT Questionnaire'}, {'measure': 'Health-related Quality of Life', 'timeFrame': 'Baseline', 'description': 'Measured using the EuroQol 5D 3L, EQ 5D-3L'}, {'measure': 'Health-related Quality of Life', 'timeFrame': '4 weeks', 'description': 'Measured using the EuroQol 5D 3L, EQ 5D-3L'}, {'measure': 'Health-related Quality of Life', 'timeFrame': '8 weeks', 'description': 'Measured using the EuroQol 5D 3L, EQ 5D-3L'}, {'measure': 'Health-related Quality of Life', 'timeFrame': 'Follow-up 3 months', 'description': 'Measured using the EuroQol 5D 3L, EQ 5D-3L'}, {'measure': "Patients' perception of improvement or decline in clinical status", 'timeFrame': '4 weeks', 'description': 'Measured using the The Patient Global Impression of Change Scale, PGIC, 1-7'}, {'measure': "Patients' perception of improvement or decline in clinical status", 'timeFrame': '8 weeks', 'description': 'Measured using the Patient Global Impression of Change Scale, PGIC, 1-7'}, {'measure': "Patients' perception of improvement or decline in clinical status", 'timeFrame': 'Follow-up 3 months', 'description': 'Measured using the Patient Global Impression of Change Scale, PGIC, 1-7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Exercise', 'Patient-centred Education', 'Randomised Controlled Trial'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effects of an eight-week exercise and patient-centred education programme with eight-week exercise alone programme on disability, pain intensity, health-related quality of life and patient global impression of change.\n\nA prospective, parallel, double-blinded and multi-centre randomised controlled trial will be carried out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016)\n\nExclusion Criteria:\n\n* Presence of uncontrolled medical disorders (cardiovascular/ metabolic/ neurological/ renal)\n* Presence of active oncological disease (or until 5 years and undergoing treatment)\n* Presence of inflammatory rheumatic diseases other than fibromyalgia\n* Presence of inflammatory osteoarticular disease or severe osteoarthritis (grade IV de Kellgren - Lawrence Classification of Osteoarthritis)\n* Previous orthopaedic (column or lower limb) or cardiothoracic surgery in the year before;\n* Disability not compatible with the exercise practice required\n* Pregnancy\n* Attendance to a physiotherapy programme including exercise in the previous three months\n* Difficulty in written communication that prevent the fulfilment of self-reported questionnaires.'}, 'identificationModule': {'nctId': 'NCT04220567', 'briefTitle': 'Effectiveness of Exercise and Patient-centred Education on Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Politécnico de Setúbal. Escola Superior de Saúde.'}, 'officialTitle': 'Is a Combined Programme of Exercise and Patient-centred Education More Effective Than Exercise Alone in Individuals With Fibromyalgia? A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'IPSetubalESS_SHARE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise and Patient-centred education', 'interventionNames': ['Other: Experimental: Exercise and Patient-centred education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'interventionNames': ['Other: Active Comparator: Exercise']}], 'interventions': [{'name': 'Experimental: Exercise and Patient-centred education', 'type': 'OTHER', 'description': "An eight-week programme based on 24 sessions of exercise supervised by a physiotherapist. Exercise will be carried out three times a week. Once a week the exercise session is performed autonomously by patient at home (according to the physiotherapist's recommendations).\n\nPatient-centred Education will follow the principles of transformative learning \\& incorporate patients' narratives. It will precede 9 of the 24 exercise sessions and be delivered by the same physiotherapist", 'armGroupLabels': ['Exercise and Patient-centred education']}, {'name': 'Active Comparator: Exercise', 'type': 'OTHER', 'description': "An eight-week programme based on 24 sessions of exercise supervised by a physiotherapist. Exercise will be carried out three times a week. Once a week the exercise session is performed autonomously by patient at home (according to the physiotherapist's recommendations).", 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2914-503', 'city': 'Setúbal', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Carmen Caeiro, PhD', 'role': 'CONTACT', 'email': 'carmen.caeiro@ess.ips.pt', 'phone': '00351 265 709 382', 'phoneExt': '5382'}, {'name': 'Patrícia Falcão, BSc Hons', 'role': 'CONTACT', 'email': 'patricia.falcao@ess.ips.pt', 'phone': '00351 265 709 382', 'phoneExt': '5382'}], 'facility': 'Carmen Caeiro', 'geoPoint': {'lat': 38.5244, 'lon': -8.8882}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Politécnico de Setúbal. Escola Superior de Saúde.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade de Lisboa - Faculdade Letras', 'class': 'UNKNOWN'}, {'name': 'Centro Hospitalar de Setúbal E.P.E.', 'class': 'UNKNOWN'}, {'name': 'Centro Hospitalar Lisboa Ocidental', 'class': 'OTHER_GOV'}, {'name': 'Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}