NCT07161245Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 2 Jun 2025
- Start date
- 6 Feb 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Hospital Clinic of Barcelona
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07161245
What you commit to
- Study type: Interventional
- Planned participants: 64
- From 6 Feb 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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)
Lab values
- Anemia with haemoglobin \<11g/dl
Age
- Age \> 80 years
Other
- 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
Who the study is looking for
- Age ≥18 years
- PBC diagnosis according to EASL guidelines
- Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.