[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587004":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":33,"centralContacts":41,"locations":47,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":103,"whyStopped":33,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Tromso","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group exercising","EXPERIMENTAL","Receives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.",[13],"Other: Group exercising",{"label":15,"type":10,"description":16,"interventionNames":17},"Somatic tracking","Receives weekly sessions of somatic tracking by a certified therapist, a wrist-worn activity tracker, and access to national recommendations on physical activity.",[18],"Other: Somatic tracking",{"label":20,"type":10,"description":21,"interventionNames":22},"Group exercising and somatic tracking","Receives weekly group exercise sessions, weekly somatic tracking sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.",[13,18],{"label":24,"type":25,"description":26,"interventionNames":27},"Control group","ACTIVE_COMPARATOR","Receives a wrist-worn activity tracker and access to national recommendations on physical activity.",[28],"Other: General activity recommendaitons",[30,34,37],{"type":6,"name":9,"description":31,"armGroupLabels":32,"otherNames":33},"Weekly, supervised exercise sessions in groups",[9,20],null,{"type":6,"name":15,"description":35,"armGroupLabels":36,"otherNames":33},"A psychological intervention aiming to learn the brain to reinterpret pain signals.",[20,15],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":33},"General activity recommendaitons","General recommendaitons for physical activity and healthy lifestyle",[24],[42],{"name":43,"role":44,"phone":45,"phoneExt":33,"email":46},"Johan Gustav Bellika","CONTACT","+4795748049","Johan.Gustav.Bellika@ehealthresearch.no",[48],{"facility":49,"status":33,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":33},"University of Tromsø","Tromsø","Troms","9019","Norway","NO",{"type":56,"coordinates":57},"Point",[58,59],18.95508,69.6489,{"lat":59,"lon":58},{"type":62,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[64],{"name":65,"class":6},"University Hospital of North Norway","100587004","fibromyalgia-somatic-tracking-and-exercise-program-study-100587004",false,"NCT06922747","FIBROmyalgia: Somatic Tracking and Exercise Program Study","FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia","FIBROSTEPS","Inclusion Criteria:\n\n* Diagnosed with fibromyalgia according to the criteria specified in Wolfe et al (2016)\n* Able to perform light physical activity\n* Able to provide written informed consent\n* Owning a smartphone\n* Able to be followed for 24 weeks\n\nExclusion Criteria:\n\n* Pregnant\n* Severe co-morbid psychiatric or neurological disorders\n* Current participation in another clinical trial\n* Recent surgery or other physical constraints preventing exercise","ALL","18 Years","65 Years",{"count":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to learn if the combination of two interventions is more effective in treating fibromyalgia symptoms than one intervention alone. The participant group will be people with fibromyalgia in age group 18-65 years. The two interventions to be tested over sixteen weeks are:\n\n* weekly exercise sessions in groups\n* weekly consultations with a therapist\n\nThe main question it aims to answer is: Is the combination of group exercising and somatic tracking work more efficient than physical activity alone in terms of managing fibromyalgia?\n\nParticipants will wear Fitbit activity trackers, register pain intensity daily on a mobile app, and answer the Fibromyalgia Impact Questionnaire (FIQ). They will be divided into four groups:\n\n* one group receiving the exercise intervention\n* one group receiving the psychological intervention\n* one group receiving both intervention\n* one control group recieving general physical activity recommendations\n\nBefore the sixteen weeks intervention period, there will be a baseline period of eight weeks. Durng the baseline period, participants will wear activity trackers and maintain their usual lifestyle.\n\nResearchers will compare the combination of the interventions against only one intervention and the control group.",[85,86,87],"Fibromyalgia (FM)","Fibromyalgia","Fibromyalgia Syndrome",[89,90,91,92,93,94,95,96,97,98,99,100,101,102],"fibromyalgia impact questionnaire","randomized controlled trial","clinical trial","factorial design","2*2 factorial design","physical activity","somatic tracking","activity","fibromyalgia","pain","effect study","musculoskeletal pain","rheumatic diseases","musculoskeletal diseases","NOT_YET_RECRUITING","2025-05-07",{"date":106,"type":107},"2025-05-13","ACTUAL",{"date":109,"type":79},"2027-01",{"date":111,"type":79},"2028-01",{"name":5,"class":6},1]