Diagnosis of liver cirrhosis (ICD-10-GM: K74.- and other etiology-specific ICD-10-GM codes) with approval for placement on the liver transplant waiting list. K74
Conditions
Interventions
Group 1: Individualized preoperative nutrition and exercise prehabilitation for liver transplant candidates (regular individualized counseling via video consultations, quarterly assessment of sarcopen
Sponsors
Universitätsklinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosis of advanced liver cirrhosis and approval for placement on the liver transplant waiting list by the Transplant Committee of the University Hospital Tübingen - Presence of malnutrition, sarcopenia, or frailty - Ability to provide written informed consent - Willingness to participate in the lifestyle intervention
Exclusion criteria
Exclusion criteria: - Acute liver failure - Diagnosed eating disorder - Physical or cognitive limitations that preclude participation in the study intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and adherence to an individualized preoperative nutritional and physical activity intervention in liver transplant candidates with sarcopenia, frailty, or malnutrition. Recruitment rate, intervention adherence, and completeness of planned assessments will be evaluated at T0 (study inclusion/baseline), T1 (during the intervention), T2 (before liver transplantation), and T3 (follow-up during routine surgical aftercare after liver transplantation) based on study and intervention documentation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Trajectory of skeletal muscle mass from T0 (baseline) to T1 (follow-up before liver transplantation, if clinically available CT imaging is performed) assessed by CT imaging (L3 skeletal muscle index). - Trajectory of muscle strength, frailty status, and functional performance from T0 to T3 assessed using a hydraulic handgrip dynamometer and the Liver Frailty Index (LFI) as part of the quarterly assessments. - Trajectory of nutritional status from T0 to T3 assessed using the Royal Free Hospital-Global Assessment (RFH-GA) and laboratory parameters as part of the quarterly assessments. - Trajectory of health-related quality of life from T0 to T3 assessed using the EQ-5D-5L (EuroQol 5-Dimension 5-Level Questionnaire). - Postoperative clinical outcomes after liver transplantation at T3 (if applicable), including postoperative complications, duration of intensive care unit stay, and hospital length of stay, assessed using clinical routine data. | — |
Countries
Germany
Contacts
Public ContactLetizia Crepaz
Allgemeine, Viszeral- und TransplantationschirurgieUniversitätsklinikum Tübingen
Outcome results
None listed