[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605340":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":34,"locations":43,"responsibleParty":57,"collaborators":23,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":23,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Multimodal prehabilitation","EXPERIMENTAL","8 weeks program of tailored physical exercise program with nutritional and psychological counselling to be carried out to a patient on the basis of his\u002Fher health condition, social circumstances and adherence profile.",[13],"Other: Multimodal prehabilitation",{"label":15,"type":6,"description":16,"interventionNames":17},"Standard of care","Standard Counselling: Patients in the control group will follow standard of care of the hospital and will be given general recommendations on physical activity, nutrition and stress\u002Fanxiety management.",[18],"Other: standard of care",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"The multimodal prehabilitation program will consist of:\n\n1. twice-weekly supervised exercise training at the hospital gym for approximately 8 weeks (induction phase), followed by 16 weeks of telematic, supervised, home-based exercise (maintenance phase);\n2. nutritional consultation, including diet optimization and supplementation if needed;\n3. individual or group-based psychological support.",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"standard of care","Participants in the control group will follow the standard of care provided by the hospital and will receive general recommendations on physical activity, nutrition, and stress\u002Fanxiety management.",[15],[29,32],{"name":30,"affiliation":5,"role":31},"Sergio Rodríguez Tajes, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":5,"role":31},"Marta Ubré Lorenzo, MD, PhD",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Helena Hernández Évole, MD","CONTACT","+34 932 27 54 00","2344","HEHERNANDEZ@clinic.cat",{"name":30,"role":37,"phone":23,"phoneExt":23,"email":42},"SRODRIGUEZ@CLINIC.CAT",[44],{"facility":45,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":23},"Hospital Clinic de Barcelona","RECRUITING","Barcelona","08036","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],2.15899,41.38879,{"lat":55,"lon":54},{"type":58,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100605340","relief-multimodal-prehabilitation-to-treat-fatigue-in-patients-with-primary-biliary-cholangitis-100605340",false,"NCT07161245","RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis","A Randomized Clinical Trial on the Improvement of Fatigue in Patients With Primary Biliary Cholangitis by Implementation of a Multimodal Rehabilitation Program and Study of Its Pathophysiological Mechanisms","RELIEF","Inclusion Criteria:\n\n* Age ≥18 years\n* PBC diagnosis according to EASL guidelines\n* Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire\n\nExclusion Criteria:\n\n* Age \\> 80 years\n* Severe pruritus\n* Decompensated cirrhosis\n* Other causes of liver disease than PBC\n* Liver transplant (LT) o placement on a waiting-list for LT\n* Uncontrolled thyroid disesase\n* Anemia with haemoglobin \\\u003C11g\u002Fdl\n* Uncontrolled cardiovascular risk factors\n* BMI \\> 35,\n* Acute myocardial infarct or unstable angina the past 6 months\n* Muscle disease or systemic disease with potential muscle involvement\n* Dysautonomy\n* Untreated osteoporosis\n* Untreated celiac disease\n* Alcohol consumption \\> 14 standard drinks (SD) in women and \\>21 (SD) in men per week\n* Chronic kidney disease ≥ 4 KDIGO stage\n* Malignancy in the past two years (except for non melanoma skin cancer and in situ cervical carcinoma)\n* Not capable of performing or following the prehabilitation program\n* Involvement in a clinical trial the previous 2 months\n* Refusal of informed consent\n\nFor the study of the pathophysiology of fatigue, additional exclusion criteria will be established: Severe depression or neuropsychiatric disease, 2) Treatment with centrally acting drugs, 3) Muscular or systemic disease with potential muscle involvement, 4) Immunosuppressive treatment, 5) Sleep disorder, 6) Obesity (BMI \\>30).",true,"ALL","18 Years","80 Years",{"count":72,"type":73},64,"ESTIMATED","INTERVENTIONAL",[76],"NA","The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients with primary biliary cholangitis. Consequently, this improvement is anticipated to enhance quality of life and cognitive symptoms, while also positively impacting emotional, social, and occupational aspects.\n\nFrom a pathophysiological perspective, it is hypothesized that chronic cholestasis and\u002For immune system activation, with the release of pro-inflammatory cytokines, leads to both central and peripheral alterations causing fatigue.\n\nAt the central level, systemic inflammation may induce neuronal senescence in the basal ganglia, resulting in altered functional connectivity networks dependent on these regions and\u002For structural and connectivity changes in areas involved in interoception, such as the insula and anterior cingulate cortex.\n\nAt the peripheral level, the hypothesis is that chronic inflammation mediated by anti-mitochondrial antibodies causes mitochondrial metabolic dysfunction in muscle cells, which would be reflected in changes observed in the gene expression analysis of these cells.\n\nImprovement in fatigue following the multimodal intervention program is expected to be associated with normalization of the immunological profile, enhanced functional brain connectivity, and improved mitochondrial metabolism in muscle.",[79],"Primary Biliary Cholangitis (PBC)",[81,82,83,84,85,86],"FATIGUE","PREHABILITATION","PHYSICAL ACTIVITY","MINDFULNESS MEDITATION","NUTRITION","QUALITY OF LIFE","2025-09-01",{"date":89,"type":90},"2025-09-08","ACTUAL",{"date":92,"type":90},"2025-02-06",{"date":94,"type":73},"2026-12-31",{"name":5,"class":6},1]