Liver Transplantation, Sarcopenia
Conditions
Keywords
Liver transplantation, Sarcopenia, Branched-chain amino acids, Muscle rehabilitation
Brief summary
Patients undergoing liver transplantation frequently experience a reduction in skeletal muscle mass, malnutrition, and decreased levels of physical activity. These complications can adversely affect early postoperative recovery and the therapeutic effect of the transplant. This clinical study aims to investigate the effects of nutritional supplementation and rehabilitation therapy on sarcopenia associated with liver transplantation in adults. The goal is to establish a comprehensive perioperative intervention strategy to reduce the incidence of postoperative sarcopenia and improve transplantation outcomes.
Interventions
DIETARY_SUPPLEMENTBCAA Nutritional Intervention
Patients will receive BCAA nutritional supplements. The supplement is taken orally twice daily, with each sachet containing 10g of powder, of which 6g is BCAA, and the remainder consists of preservatives and fruit flavorings to enhance palatability. The morning dose is taken with breakfast, and the second dose is taken as a late evening snack after dinner. For critically ill patients, enteral nutrition is provided instead. During each follow-up visit, patients are required to retain and submit all empty and unused sachets to accurately assess compliance. Dietitians will adjust the type and amount of food for each patient according to the guidelines of the European Society for Parenteral and Enteral Nutrition to ensure a total caloric intake of 35-40 kcal/kg and a protein intake of 1.2-1.5 g/kg (including BCAA supplements).
BEHAVIORALMuscle Rehabilitation Training
Phase 1: Resistance Training (During Hospital Stay, First Month) Phase 2: Resistance Training (Home-Based, From Hospital Discharge Until 3 Months Post-Surgery) Phase 3: Physical Activity Training (Post-Surgery, After 3 Months)
DIETARY_SUPPLEMENTStandard Nutritional Therapy
Standard Nutritional Therapy
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 70 years. 2. Patients with end-stage liver disease who meet the criteria for liver transplantation (for liver cancer cases, only recipients meeting specific standards are included). 3. Complete clinical information, including documented pre-transplant muscle status (e.g., preoperative CT scans and handgrip strength tests). 4. High compliance with treatment, fully capable of independent action or having at least one assistant. 5. No contraindications to the planned interventions.
Exclusion criteria
1. Presence of musculoskeletal disorders before transplantation, such as myositis, idiopathic muscle atrophy, or history of hip surgery within the past three months. 2. Coexisting severe cardiovascular or cerebrovascular diseases, infectious diseases, or epilepsy. 3. Liver transplantation due to autoimmune liver disease or drug-induced liver failure. 4. Re-transplantation, multi-organ transplantation, living donor liver transplantation, split liver transplantation, or pediatric liver transplantation. 5. ABO-incompatible liver transplantation. 6. Incomplete clinical information. 7. Difficulty in follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year overall survival | From enrollment to the end of follow-up at 2 years | At the 2-year mark, record the survival status of each patient (alive or deceased). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | From enrollment to the end of treatment at 6 months | Muscle mass can be assessed using various methods, including CT-based Skeletal Muscle Index (SMI) calculation at the L3 vertebra, which measures the cross-sectional area of muscle normalized by height; handgrip strength testing, which evaluates muscle function; bioelectrical impedance analysis (BIA) for body composition; MRI for precise muscle volume measurements; and dual-energy X-ray absorptiometry (DXA) for assessing lean body mass. These methods provide a comprehensive evaluation of muscle health. |
Contacts
Primary ContactZuyuan Lin
Outcome results
None listed