SONIC
Research type
Research Study
Full title
Evaluation of lifeStyle factors On fatigue iN Primary BilIary Cholangitis: the SONIC study: The SONIC Study
IRAS ID
347250
Contact name
Felicity Rhian Williams
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
Fatigue affects 7/10 individuals independent of disease severity and significantly impairs QoL. As a concept, fatigue is often described as either central or peripheral. Central fatigue is often associated with daytime somnolence (“sleepiness”), cognitive impairment (brain fog), and/or poor concentration. Whereas peripheral fatigue tends to refer more to “muscle fatigue,” and exhaustion with minimal physical exertion (3) Preliminary data in primary biliary cholangitis (PBC), suggests fatigue in cholestasis is likely multifactorial, with contributions from both central (i.e. decrease in voluntary activation of muscle relating to a decline in motor cortex drive) and peripheral components (i.e. decrease in contractile strength and endurance relating to altered muscle action potential mechanisms) but this remains within its infancy.
It is widely reported by the UK-based PBC patient groups that fatigue is the symptom that they find most burdensome. Currently, there is no cure for fatigue in PBC and management does not extend beyond control of medical symptoms and comorbidities (i.e. pruritis, hypothyroidism, anaemia), empathy and generic advice around pacing, sleep and coping strategies. This is in large due to the limited understanding of the basic driving mechanisms of fatigue in this cohort and a profound lack of research into treatments such as exercise and sleep strategies to mitigate this burden.
Aims/Objectives
The primary aim of the study is to investigate whether lifestyle factors such as physical activity and sleep are associated with perceived fatigue in patients with PBC.The secondary aims:
Lifestyle factors such as physical activity and sleep in PBC are associated with objective measures of peripheral fatigue (i.e. ISWT, time to task failure hand grip strength, repeated chair stands)
Perceived and objective measures of fatigue are associated with quality of life, demographic and clinical factors
Physical activity and/or sleep profiles influence responsiveness to medical therapy (i.e. response to Ursodeoxycholic Acid).REC name
West of Scotland REC 4
REC reference
25/WS/0104
Date of REC Opinion
27 Aug 2025
REC opinion
Further Information Favourable Opinion