Multimodal prehabilitation to reduce fatigue in 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
NA · Hospital Clinic of Barcelona · NCT07161245
This trial will try a combined program of supervised exercise, nutritional counseling, and mindfulness to reduce fatigue in adults with primary biliary cholangitis who have moderate-to-severe fatigue.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona (other) |
| Drugs / interventions | rituximab |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT07161245 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with a confirmed PBC diagnosis and moderate-to-severe fatigue (PBC-40 score ≥29) who are physically able and willing to follow a structured exercise, nutrition, and psychological program are the intended candidates.
Not a fit: Patients with decompensated cirrhosis, uncontrolled cardiovascular or metabolic disease, significant musculoskeletal limitations, very high BMI, recent malignancy, or those unable to participate in or adhere to the program are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could reduce fatigue and improve quality of life, cognition, and daily functioning without adding new medications.
How similar studies have performed: Pharmacologic trials for PBC-related fatigue have largely been negative, and while exercise or mindfulness have shown benefits in other fatigue conditions, multimodal prehabilitation for PBC is relatively novel with limited direct trial evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Barcelona, Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Biliary Cholangitis, FATIGUE, PREHABILITATION, PHYSICAL ACTIVITY, MINDFULNESS MEDITATION, NUTRITION, QUALITY OF LIFE