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

What this Trial Is About

Researchers are investigating a non-drug multimodal intervention program to improve fatigue in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease that severely impacts quality of life through symptoms like "brain fog" and lack of energy. Fatigue in PBC is believed to result from chronic inflammation affecting both brain function and muscle metabolism, though current treatments have not effectively addressed this symptom. The study compares a tailored multimodal prehabilitation program including twice-weekly supervised exercise for 8 weeks followed by 16 weeks of remote supervised home exercise, combined with nutritional counseling and psychological support, against standard care with general physical activity, nutrition, and stress management advice. This program aims to improve fatigue, quality of life, cognitive symptoms, and emotional well-being. Participants will be assessed at baseline, after 8 weeks, and at 6 months for fatigue severity, cognitive and extrahepatic symptoms, quality of life, anxiety, depression, sleep quality, work productivity, systemic inflammation, brain connectivity by fMRI, and muscle metabolism through gene expression analysis obtained via muscle microbiopsy. Safety and satisfaction with the program will also be monitored throughout the study period.

RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis