Events schedule
Events schedule | |||||||
Procedure | Screening | T0 | First study period | T1 | Second study period | T2 | T3 |
Week | 0 | 0 | 0–6 | 6 | 12-Jun | 12 | 18 |
Eligibility assessment | |||||||
Informed consent | X | ||||||
Inclusion/exclusion criteria | X | ||||||
Study assessments | |||||||
Aerobic fitness | |||||||
CPET | X | X* | X | X | X | X | X |
Steep ramp test | X | X | |||||
Sarcopenia | |||||||
Muscle thickness | X | X | X | X | |||
SARC-F questionnaire | X | X | X | X | |||
Liver disease specific frailty | |||||||
Liver Frailty Index | X | X | X | X | |||
Anthropometry | |||||||
BMI | X | X | X | X | |||
Quality of life | |||||||
SF-36 | X | X | X | X | |||
LDSI | X | X | X | X | |||
Perceived fatigue | |||||||
MFI | X | X | X | X | |||
Anxiety and depression | |||||||
STAI-6 | X | X X | X X | X X | |||
PHQ-9 | X | ||||||
Hepatic encephalopathy | |||||||
West Haven | X | X | X | X | |||
ANT | X | X | X | X | |||
Microbiome composition | |||||||
Stool sample | X | X | X | X |
*Results of the screening CPET are used for the T0 assessment.
ANT, animal naming test; BMI, body mass index; CPET, cardiopulmonary exercise test; LDSI, liver disease symptom index; MFI, multidimensional fatigue index; PHQ-9, 9-item Patient Health Questionnaire; SARC-F, Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls; SF-36, 36 item short form; STAI-6, 6 item Spielberger State-Trait Anxiety Inventory.