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RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis

RecruitingNAAges 18 Years - 80 YearsAllHospital Clinic of Barcelona
NCT07161245 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. From a pathophysiological perspective, it is hypothesized that chronic cholestasis and/or immune system activation, with the release of pro-inflammatory cytokines, leads to both central and peripheral alterations causing fatigue. At the central level, systemic inflammation may induce neuronal senescence in the basal ganglia, resulting in altered functional connectivity networks dependent on these regions and/or structural and connectivity changes in areas involved in interoception, such

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * PBC diagnosis according to EASL guidelines * Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire Exclusion Criteria: * Age \> 80 years * Severe pruritus * Decompensated cirrhosis * Other causes of liver disease than PBC * Liver transplant (LT) o placement on a waiting-list for LT * Uncontrolled thyroid disesase * Anemia with haemoglobin \<11g/dl * Uncontrolled cardiovascular risk factors * BMI \> 35, * Acute myocardial infarct or unstable angina the past 6 months * Muscle disease or systemic disease with potential muscle involvement * Dysautonomy * Untreated osteoporosis * Untreated celiac disease * Alcohol consumption \> 14 standard drinks (SD) in women and \>21 (SD) in men per week * Chronic kidney disease ≥ 4 KDIGO stage * Malignancy in the past two years (except for non melanoma skin cancer and in situ cervical carcinoma) * Not capable of performing or following the prehabilitation program * Involvement in a clinical trial the previous 2 months * Refusal of informed consent For 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).
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What it tests

  • Multimodal prehabilitation
  • standard of care
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Where

1 site
Hospital Clinic de Barcelona
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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