[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616327":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Halic University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exergame group","EXPERIMENTAL","Participants in this group will perform exergame-based exercises.",[13],"Other: Exergaming",{"label":15,"type":10,"description":16,"interventionNames":17},"Home-based exercise group","Participants in this group will perform home-based exercise sessions.",[18],"Other: Home-based exercise",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Exergaming","Participants in the exergame group will perform exercises using the Nintendo Switch game Ring Fit Adventure under the supervision of a physiotherapist, twice a week for four weeks. The exergame program was designed by a specialist physiotherapist.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Home-based exercise","Participants in the home-based exercise group will perform exercises prescribed by a specialist physiotherapist as a home program, twice a week for four weeks. The exercises will be taught to participants in face-to-face sessions. Once a week, participants in the home-based exercise group will meet via Zoom to monitor exercise accuracy and progression. The home-based exercise program was adapted from the study conducted by Gentile et al. (2024).",[15],[30],{"name":31,"affiliation":5,"role":32},"Gülhan Fetin, PT","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Ayşenur Çetinkaya, PhD","CONTACT","+905077218827","aysenurcetinkaya@halic.edu.tr",{"name":40,"role":36,"phone":41,"phoneExt":24,"email":38},"Ayşenur Çetinkaya","905077218827",[43],{"facility":5,"status":44,"city":45,"state":24,"zip":24,"country":46,"countryCode":24,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Istanbul","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],28.94966,41.01384,{"lat":51,"lon":50},[54],{"name":40,"role":36,"phone":24,"phoneExt":24,"email":38},{"type":32,"investigatorFullName":40,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PT, PhD","100616327","investigation-of-the-effectiveness-of-a-exergame-program-in-women-with-fibromyalgia-100616327",false,"NCT07304167","Investigation of the Effectiveness of a Exergame Program in Women With Fibromyalgia","Investigation of the Effectiveness of a Video-Based Exercise (Exergame) Program in Women With Fibromyalgia: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged between 30 and 70 years, which is an age range in which fibromyalgia (FM) is more prevalent;\n* Having a diagnosis of fibromyalgia;\n* Being willing to participate in the study and signing the informed consent form;\n* Meeting the 2016 American College of Rheumatology (ACR) diagnostic criteria, defined as a Widespread Pain Index (WPI) ≥ 7 and a Symptom Severity Scale (SSS) score ≥ 5, or WPI = 4-6 and SSS ≥ 9.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Any known advanced pathology related to the locomotor system that contraindicates physical activity (such as arthritis, osteoarthritis, or uric acid disorders)\n* Epilepsy\n* History of severe headache\n* Neurological disorder\n* Peripheral neuropathy\n* Known severe cardiovascular disease (such as endocranial hypertension, uncontrolled arterial hypertension, heart failure, or presence of a pacemaker)\n* Orthopedic disorders of the upper or lower extremities that prevent participation in physical activity\n* Rheumatologic disease other than fibromyalgia\n* Pneumothorax\n* Neoplasia\n* Surgery within the last four months\n* Severe psychiatric illness (such as uncontrolled depression and anxiety, personality disorders, dementia, or cognitive impairments related to substance abuse)\n* Diagnosis of alcohol dependence or use of psychoactive drugs or narcotics\n* Participation in any physical activity program within two months prior to the start of the study\n* Body mass index (BMI) greater than 29.9","FEMALE","30 Years","70 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to compare the effects of an exergame-based exercise program and a home-based exercise program in women aged 30-70 years diagnosed with fibromyalgia (FM).\n\nThe main questions it aims to answer are:\n\nDoes an exergame-based program using the Nintendo Switch game Ring Fit Adventure improve pain, balance, and functional mobility in women with fibromyalgia? Is the exergame program more effective than a traditional home-based exercise program in improving physical and psychosocial outcomes? Researchers will compare the exergame group and the home-based exercise group to determine whether game-based exercises provide superior benefits in pain reduction, balance, and quality of life.\n\nParticipants will:\n\nBe randomly assigned to either the exergame or the home-based exercise group. Exercise twice a week for four weeks under the supervision of a physiotherapist or via remote monitoring.\n\nUndergo evaluations before and after the 4-week training period, and again after a 4-week detraining period.\n\nAssessments will include:\n\nPain intensity (Visual Analog Scale) Disease severity (Revised Fibromyalgia Impact Questionnaire, Widespread Pain Index, Symptom Severity Scale, Fibromyalgia Severity Scale) Lower extremity strength (Sit-to-Stand Test) Functional mobility (Timed Up and Go Test) Balance (Single-Leg Stance Test, Berg Balance Scale) Psychosocial status (Cognitive Exercise Therapy Approach Questionnaire - BETY-BQ) Quality of life (Short Form-12) Study findings are expected to provide evidence for the effectiveness of exergame applications as an enjoyable rehabilitation approach for individuals with fibromyalgia.",[75,21],"Fibromyalgia",[75,21,77,78],"Exercise","Rehabilitation","2026-01-08",{"date":81,"type":82},"2026-01-09","ACTUAL",{"date":84,"type":82},"2025-12-15",{"date":86,"type":69},"2026-03-05",{"name":5,"class":6},1]