[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613062":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":54,"collaborators":23,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":23,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":23,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":23,"overallStatus":77,"whyStopped":23,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Nigde Omer Halisdemir University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Group","EXPERIMENTAL","Training at 30% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week",[13],"Other: Exercise",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham group","SHAM_COMPARATOR","Training at 0-10% of maximum inspiratory pressure for 6 weeks, 2 sessions per day, 7 days a week",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Control group","NO_INTERVENTION","No Intervention",null,[25],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"Exercise","Inspiratory muscle training program will be applied to the study and sham group for 7 days\u002F6 weeks.",[15,9],[30],{"name":31,"affiliation":32,"role":33},"Gürkan Demirtaş, PhD","Niğde Ömer Halisdemir University","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":23,"email":38},"CONTACT","+90 388 311 2105","gurkandemirtas@ohu.edu.tr",[40],{"facility":41,"status":23,"city":42,"state":43,"zip":44,"country":45,"countryCode":23,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Niğde Ömer Halisdemir Üniversitesi","Niğde","Niğde Province","51200","Turkey (Türkiye)",{"type":47,"coordinates":48},"Point",[49,50],34.67935,37.96583,{"lat":50,"lon":49},[53],{"name":31,"role":36,"phone":37,"phoneExt":23,"email":38},{"type":33,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Gürkan Demirtas","PhD","100613062","the-effects-of-inspiratory-muscle-training-female-patients-with-fibromyalgia-100613062",false,"NCT07261696","The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia","The Effects of Inspiratory Muscle Training on the Autonomic Nervous System and Clinical Symptoms in Female Patients With Fibromyalgia","Inclusion Criteria:\n\n* Be aged between 18 and 65 years old,\n* Have been diagnosed with fibromyalgia according to the 2010\u002F2016 ACR criteria,\n* Be female,\n* Have moderate pain lasting at least 3 months and defined as at least 30 mm on the 0-100 mm visual analogue scale (VAS).\n\nExclusion Criteria:\n\n* Presence of chronic heart disease,\n* Current use of narcotic drugs,\n* History of asthma or other chronic respiratory diseases,\n* Pregnancy,\n* Diabetes, kidney, adrenal, pituitary or thyroid disorders,\n* History of serious neurological or psychiatric disorders (e.g. mania, psychosis, suicidal tendencies, bipolar disorder, schizophrenia, autism spectrum disorders),\n* Neurodegenerative diseases (e.g. Parkinson's, Alzheimer's, Huntington's disease),\n* Head trauma, migraine,\n* Presence of active cardiac implants.","FEMALE","18 Years","65 Years",{"count":68,"type":69},51,"ESTIMATED","INTERVENTIONAL",[72],"NA","Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and psychological symptoms. Autonomic nervous system (ANS) dysfunction, marked by increased sympathetic and reduced parasympathetic activity, is considered one of its possible mechanisms. Although exercise is recommended in treatment, low motivation and fatigue often limit participation. Therefore, inspiratory muscle training (IMT), which targets the respiratory muscles, is seen as an easy-to-apply alternative.This randomized, controlled, double-blind study will be conducted at Niğde Ömer Halisdemir University Hospital. Fifty-one women aged 18-65 years who meet the 2010\u002F2016 ACR criteria for fibromyalgia will be randomly assigned to three groups: training (30% of maximal inspiratory pressure), sham (0-10%), and control (no training). ANS functions will be assessed using heart rate variability and the COMPASS-31 questionnaire. Pain, sleep quality, fatigue, anxiety, depression, and respiratory muscle strength will also be evaluated. Training will be performed with the Powerbreathe® device twice daily for six weeks.The study aims to investigate the effects of IMT on ANS functions in fibromyalgia and to explore its relationship with symptoms such as pain, fatigue, sleep disturbances, anxiety, and depression.",[75,76],"Fibromyalgia","Autonomic Dysfunction","NOT_YET_RECRUITING","2025-11-21",{"date":80,"type":81},"2025-12-03","ACTUAL",{"date":83,"type":69},"2025-12-05",{"date":85,"type":69},"2026-12-05",{"name":5,"class":6},1]