Exercise, Nutrition and Support Program to Ease Fatigue in Primary Biliary Cholangitis
Tests a multimodal prehabilitation program for fatigue in adults with primary biliary cholangitis.
Plain-language title generated from the registry record
Registry title: RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis
Key facts
- Where
- Barcelona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07161245, who can take part
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Clinic of Barcelona
- Trial code
- NCT07161245
- Record updated
- 8 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥18 years; PBC diagnosis according to EASL guidelines; Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire.
Exclusion: Liver transplant (LT) o placement on a waiting-list for LT; 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); Other causes of liver disease than PBC; Acute myocardial infarct or unstable angina the past 6 months; Muscle disease or systemic disease with potential muscle involvement; Untreated celiac disease; Chronic kidney disease ≥ 4 KDIGO stage; Malignancy in the past two years (except for non melanoma skin cancer and in situ cervical carcinoma); Anemia with haemoglobin <11g/dl; Age > 80 years; Severe pruritus; Decompensated cirrhosis; Uncontrolled thyroid disesase; Uncontrolled cardiovascular risk factors; BMI > 35,; Dysautonomy; Untreated osteoporosis; Alcohol consumption > 14 standard drinks (SD) in women and >21 (SD) in men per week; Not capable of performing or following the prehabilitation program.