Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation

Not Applicable

Not yet recruiting

• Conditions: Liver Transplantation; Sarcopenia
• Interventions: Dietary Supplement: BCAA Nutritional Intervention; Dietary Supplement: Standard Nutritional Therapy; Behavioral: Muscle Rehabilitation Training

• Registration Number: NCT06591507
• Lead Sponsor: Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Study Start: 2024-10-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative and Postoperative BCAA Nutritional Intervention	BCAA Nutritional Intervention	-
Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation	BCAA Nutritional Intervention	-
Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation	Muscle Rehabilitation Training	-
Postoperative BCAA Nutritional Intervention	BCAA Nutritional Intervention	-
Postoperative Muscle Rehabilitation	Muscle Rehabilitation Training	-
Standard Nutritional Therapy	Standard Nutritional Therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.