Status:
RECRUITING
RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Primary Biliary Cholangitis (PBC)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients wi...
Detailed Description
Primary biliary cholangitis (PBC) is a rare autoimmune disease that damages the small bile ducts and primarily affects women. Although it is a liver disease, its most common symptom is fatigue, affect...
Eligibility Criteria
Inclusion
- Age ≥18 years
- PBC diagnosis according to EASL guidelines
- Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire
Exclusion
- 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).
Key Trial Info
Start Date :
February 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT07161245
Start Date
February 6 2025
End Date
December 31 2026
Last Update
September 8 2025
Active Locations (1)
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1
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036