The EXCITED study
Research type
Research Study
Full title
EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED study
IRAS ID
253115
Contact name
Alice Elizabeth Vallance
Contact email
Sponsor organisation
Name of organisation University Hospitals Birmingham
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Varying in its intensity, fatigue is an identifiable and apparent symptom associated with Primary Biliary Cholangitis (PBC) and often not seen in isolation. Related symptoms including cognitive impairment, worsening quality of life and mood as a consequence of limited participation in activities of daily living all contribute to a reduction in health and wellbeing in this population. Fatigue is not known to be a direct link to underlying severity of liver disease, however has been associated with increased mortality in those not transplanted relative to those that do not exhibit fatigue. In addition to this, it has also been identified that an overall increased incidence of fatigue correlates to reduced baseline physical activity and participation.
Fatigue can be characterised into two forms, peripheral and central. Peripheral fatigue relates to neuromuscular dysfunction and occurs due to muscle over activity and its associated processes causing weakness. As it suggests, central fatigue arises within the central nervous system and impairs physical and mental performance and is seen commonly in liver disease. Fatigue is a complex symptom of PBC and is thought to have many contributing factors including anaemia, psychological distress, poor sleep quality and depression alongside physiological changes within the muscle including excessive acidosis.
Although it is widely accepted that fatigue is a common symptom of PBC, it is not fully understood how exercise can impact upon this symptom and associated benefits of functional capacity and quality of life. The proposed study will involve recruiting an eligible population with PBC that can participate in home-based exercise training with the primary outcome focusing on quality of life and levels of fatigue.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/2109
Date of REC Opinion
2 Jan 2019
REC opinion
Further Information Favourable Opinion