[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658397":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":48,"interventions":60,"overallOfficials":39,"centralContacts":74,"locations":39,"responsibleParty":80,"collaborators":39,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":39,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":106,"whyStopped":39,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":39},{"fullName":5,"class":6},"Istinye University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":39},[9,13],{"measure":10,"description":11,"timeFrame":12},"Interleukin-6 (IL-6)","Changes in serum interleukin-6 (IL-6) concentration will be assessed using standardized laboratory assay methods to evaluate the biological effects of aerobic exercise with or without Basic Body Awareness Therapy in women with fibromyalgia.","Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.",{"measure":14,"description":15,"timeFrame":12},"Cortisol","Changes in cortisol concentration will be assessed using standardized laboratory assay methods to evaluate the biological effects of aerobic exercise with or without Basic Body Awareness Therapy in women with fibromyalgia.",[17,20,23,26,29,32,35],{"measure":18,"description":19,"timeFrame":12},"Cognitive Function Assessed by Trail Making Test","Cognitive function including attention, processing speed, executive function, and cognitive flexibility will be evaluated using the Trail Making Test (Parts A and B).",{"measure":21,"description":22,"timeFrame":12},"Depression Level Measured by Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale","Depression levels will be assessed using the Depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21).",{"measure":24,"description":25,"timeFrame":12},"Pain Intensity Measured by Visual Analog Scale (VAS)","Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS).",{"measure":27,"description":28,"timeFrame":12},"Pressure Pain Threshold Measured by Pressure Algometer","Pressure pain threshold will be measured using a pressure algometer at standardized tender point sites.",{"measure":30,"description":31,"timeFrame":12},"Fibromyalgia Disease Severity Assessed by Revised Fibromyalgia Impact Questionnaire (FIQR)","Disease severity will be evaluated using the Revised Fibromyalgia Impact Questionnaire (FIQR).",{"measure":33,"description":34,"timeFrame":12},"Health-Related Quality of Life Measured by SF-36","Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36).",{"measure":36,"description":37,"timeFrame":38},"Cognitive Function Assessed by Stroop Test","Cognitive function including attention, processing speed, executive function, and cognitive flexibility will be evaluated using the Stroop Test.","Baseline (before the first exercise session) and at the end of 12 weeks.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of two parallel groups. The intervention group will receive moderate-intensity aerobic exercise combined with Basic Body Awareness Therapy, while the control group will receive moderate-intensity aerobic exercise only. Outcomes will be assessed at baseline and after the intervention period.","TREATMENT",{"masking":46,"maskingDescription":47,"whoMasked":39},"NONE","This study is conducted as an open-label trial. Due to the nature of the interventions (aerobic exercise and Basic Body Awareness Therapy), blinding of participants, care providers, and investigators is not feasible. All participants and researchers are aware of group allocation throughout the study period.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Aerobic Exercise + Basic Body Awareness Therapy","EXPERIMENTAL","Participants in this group will receive a supervised moderate-intensity aerobic exercise program combined with Basic Body Awareness Therapy. The aerobic exercise program will be administered according to standardized protocols, and Basic Body Awareness Therapy will be applied as an adjunct intervention focusing on posture, movement quality, breathing, and body awareness. The intervention will be conducted over the predefined study period under the supervision of a physiotherapist.",[54],"Behavioral: Basic Body Awareness Therapy",{"label":56,"type":51,"description":57,"interventionNames":58},"Aerobic Exercise Only","Participants in this group will receive a supervised moderate-intensity aerobic exercise program according to standardized protocols. No additional therapeutic interventions will be applied. The intervention will be conducted over the predefined study period under the supervision of a physiotherapist.",[59],"Behavioral: Moderate-Intensity Aerobic Exercise",[61,68],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"BEHAVIORAL","Basic Body Awareness Therapy","Basic Body Awareness Therapy is a physiotherapy-based intervention focusing on movement awareness, posture, balance, breathing, and body perception. The therapy aims to improve movement quality and bodily awareness through guided exercises performed in standing, sitting, and lying positions. Sessions are conducted by a trained physiotherapist according to standardized principles of Basic Body Awareness Therapy.",[50],[67],"BBAT",{"type":62,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Moderate-Intensity Aerobic Exercise","Moderate-intensity aerobic exercise consists of structured physical activity designed to improve cardiovascular endurance. Exercise intensity is prescribed and monitored according to standardized guidelines. The program is supervised by a physiotherapist and performed regularly throughout the intervention period.",[56],[73],"Aerobic exercise training",[75],{"name":76,"role":77,"phone":78,"phoneExt":39,"email":79},"Hacer ÖNEN TEKİN, MSc","CONTACT","+905414202156","229912820@stu.istinye.edu.tr",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"SPONSOR_INVESTIGATOR","Hacer Önen Tekin","Investigator","100658397","effects-of-basic-body-awareness-therapy-added-to-aerobic-exercise-in-women-with-fibromyalgia-100658397",false,"NCT07851896","Effects of Basic Body Awareness Therapy Added to Aerobic Exercise in Women With Fibromyalgia","Effects of Basic Body Awareness Therapy Added to Moderate-Intensity Aerobic Exercise on IL-6, Cortisol Levels, Cognitive Function, and Depression in Women With Fibromyalgia: A Randomized Controlled Trial","BBAT-FMS","Inclusion Criteria:\n\n* Female participants aged 30 to 50 years\n* Diagnosed with fibromyalgia according to established diagnostic criteria\n* Presence of fibromyalgia-related symptoms for at least 3 months\n* Physically inactive according to the International Physical Activity Questionnaire (IPAQ) - Short Form (weekly physical activity level \\\u003C 600 MET-min\u002Fweek)\n* Willingness to participate voluntarily in the exercise program twice per week for 12 weeks\n* Ability to understand study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of any central or peripheral nervous system disease\n* Presence of progressive neurological disorders\n* Uncontrolled hypertension\n* Presence of cardiovascular disease or pathology\n* Use of psychotropic medications within the past 1 month\n* Presence of any musculoskeletal disorder other than fibromyalgia\n* Pregnancy\n* Presence of cognitive impairment that may affect cooperation or compliance with study procedures","FEMALE","30 Years","50 Years",{"count":96,"type":97},40,"ESTIMATED","INTERVENTIONAL",[100],"NA","This study aims to investigate the effects of Basic Body Awareness Therapy combined with aerobic exercise on inflammatory biomarkers (interleukin-6 and cortisol), cognitive functions, and depression levels in women diagnosed with fibromyalgia syndrome. Participants will be randomly assigned to an intervention group receiving aerobic exercise plus Basic Body Awareness Therapy or a control group receiving aerobic exercise alone. Clinical, biochemical, cognitive, and psychological assessments will be conducted at baseline and after the intervention period. The findings are expected to contribute to evidence-based non-pharmacological rehabilitation approaches for fibromyalgia management.",[103],"Fibromyalgia Syndrome",[105],"Basic Body Awareness; Fibromyalgia; Exercise; Cortisol; Interleukin-6","NOT_YET_RECRUITING","2026-09-25",{"date":109,"type":110},"2026-10-01","ACTUAL",{"date":112,"type":97},"2026-10-15",{"date":114,"type":97},"2027-11-15",{"name":82,"class":6}]