Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-27 @ 10:32 AM
Study NCT ID:
NCT03736733
Status:
COMPLETED
Last Update Posted:
2022-09-29
First Post:
2018-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the impact of a 3-month program', 'timeFrame': 'at 3 months', 'description': 'Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).'}], 'secondaryOutcomes': [{'measure': 'fatigue', 'timeFrame': 'at 3 months', 'description': 'assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7.\n\nSimply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5'}, {'measure': 'Quality of sleep', 'timeFrame': 'at 3 months', 'description': 'assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score.\n\nThe 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3.\n\nIn all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.'}, {'measure': 'Anxiety and Depression', 'timeFrame': 'at 3 months', 'description': 'assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.'}, {'measure': 'pain catastrophizing', 'timeFrame': 'at 3 months', 'description': 'assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time'}, {'measure': 'pain evaluation', 'timeFrame': 'at 3 months', 'description': 'assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)'}, {'measure': 'muscle power', 'timeFrame': 'at 3 months', 'description': 'evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.'}, {'measure': 'muscular endurance', 'timeFrame': 'at 3 months', 'description': 'evaluated by dynamometry on a stress platform (arms and legs).'}, {'measure': 'gas exchange measurement', 'timeFrame': 'at 3 months', 'description': 'evaluated during a stress test'}, {'measure': 'quantification of physical activity in meter-h/week', 'timeFrame': 'at 3 months', 'description': 'evaluated by the APAQ : Adult Physical Activity Questionnaire'}, {'measure': 'sedentary times in hours/day', 'timeFrame': 'at 3 months', 'description': 'evaluated by the APAQ : Adult Physical Activity Questionnaire'}, {'measure': 'daily energy expenditure', 'timeFrame': 'at 3 months', 'description': 'evaluated by actimetry'}, {'measure': 'time of physical activity', 'timeFrame': 'at 3 months', 'description': 'evaluated by actimetry'}, {'measure': 'physical inactivity', 'timeFrame': 'at 3 months', 'description': 'evaluated by actimetry'}, {'measure': 'patient adherence', 'timeFrame': 'at 3, 6 and 12 months', 'description': 'number of sessions performed'}, {'measure': 'Direct medical costs', 'timeFrame': 'at 3, 6 and 12 months', 'description': 'consultations, examinations, hospitalizations in euros'}, {'measure': 'Direct non-medical costs', 'timeFrame': 'at 3, 6 and 12 months', 'description': 'transport'}, {'measure': 'Cost of lost productivity', 'timeFrame': 'at 3, 6 and 12 months', 'description': 'time not worked'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sedentary time'], 'conditions': ['Fibromyalgia', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.\n\nThe diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.\n\nThus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient lived in t Loire (42) or Haute-Loire (43)\n* Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13\n* French writing and speaking\n* Sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion)\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Cardiac or respiratory diseases that contraindicate the practice of physical activity\n* Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).\n* Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason'}, 'identificationModule': {'nctId': 'NCT03736733', 'acronym': 'FIMOUV 1', 'briefTitle': 'Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.', 'orgStudyIdInfo': {'id': '18CH051'}, 'secondaryIdInfos': [{'id': '2018-A01597-48', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fibromyalgia patients with physical activity program', 'description': 'Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.', 'interventionNames': ['Other: physical activity program']}, {'type': 'OTHER', 'label': 'fibromyalgia patients with physical activity at home', 'description': 'Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).', 'interventionNames': ['Other: Advice and recommendations of physical activity at home']}], 'interventions': [{'name': 'physical activity program', 'type': 'OTHER', 'description': 'Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.', 'armGroupLabels': ['fibromyalgia patients with physical activity program']}, {'name': 'Advice and recommendations of physical activity at home', 'type': 'OTHER', 'description': 'Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).', 'armGroupLabels': ['fibromyalgia patients with physical activity at home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'David HUPIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}