Multimodal prehabilitation to reduce fatigue in primary biliary cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares a non-pharmacological multimodal prehabilitation program—composed of physical exercise, individualized nutritional counseling, and psychological support including mindfulness meditation—with standard of care in adults with primary biliary cholangitis. Eligible participants are adults diagnosed according to EASL guidelines who report moderate-to-severe fatigue (PBC-40 fatigue score ≥29). The study will monitor changes in fatigue severity, quality of life, cognitive symptoms, and functional and occupational outcomes during and after the intervention. The protocol is grounded in a hypothesis that systemic inflammation and peripheral changes drive central and peripheral mechanisms of fatigue in PBC.

Why it matters

Who can join: the full rules

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).

Where it's running

• Hospital Clinic de Barcelona
  Barcelona, Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Sergio Rodríguez Tajes, MD, PhD — Hospital Clinic of Barcelona
• Study coordinator: Helena Hernández Évole, MD
• Email: HEHERNANDEZ@clinic.cat
• Phone: +34 932 27 54 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using Fenofibrate with Ursodeoxycholic Acid for Primary Biliary Cholangitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.