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

Recruiting now · Not applicable

Conditions studied: Primary Biliary Cholangitis (PBC)

In brief

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 as the insula and anterior cingulate cortex. At 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. Improvement 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.

Key facts

Study ID

NCT07161245

Run by

Hospital Clinic of Barcelona

People needed

64

Starts

2025-02-06

Expected to finish

2026-12-31

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥18 years
• PBC diagnosis according to EASL guidelines
• Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire

You may not qualify if…

• 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).

Where it is running

• Hospital Clinic de Barcelona — Barcelona, Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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