Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation

Zhejiang University

Status: Not yet enrolling

Conditions: Liver Transplantation; Sarcopenia

Treatments: Dietary Supplement: BCAA Nutritional Intervention; Behavioral: Muscle Rehabilitation Training; Dietary Supplement: Standard Nutritional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06591507

CT2024-ZJU-RCT1

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 5 patient groups, including a placebo group

Preoperative and Postoperative BCAA Nutritional Intervention

Experimental group

Treatment:

Dietary Supplement: BCAA Nutritional Intervention

Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation

Experimental group

Treatment:

Behavioral: Muscle Rehabilitation Training

Dietary Supplement: BCAA Nutritional Intervention

Postoperative BCAA Nutritional Intervention

Experimental group

Treatment:

Dietary Supplement: BCAA Nutritional Intervention

Postoperative Muscle Rehabilitation

Experimental group

Treatment:

Behavioral: Muscle Rehabilitation Training

Standard Nutritional Therapy

Placebo Comparator group

Treatment:

Dietary Supplement: Standard Nutritional Therapy