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NCT Number: NCT06591507

Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation

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.

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Key information

Conditions

Liver Transplantation Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 70 years.
  • Patients with end-stage liver disease who meet the criteria for liver transplantation (for liver cancer cases, only recipients meeting specific standards are included).
  • Complete clinical information, including documented pre-transplant muscle status (e.g., preoperative CT scans and handgrip strength tests).
  • High compliance with treatment, fully capable of independent action or having at least one assistant.
  • No contraindications to the planned interventions.

Exclusion criteria

  • Presence of musculoskeletal disorders before transplantation, such as myositis, idiopathic muscle atrophy, or history of hip surgery within the past three months.
  • Coexisting severe cardiovascular or cerebrovascular diseases, infectious diseases, or epilepsy.
  • Liver transplantation due to autoimmune liver disease or drug-induced liver failure.
  • Re-transplantation, multi-organ transplantation, living donor liver transplantation, split liver transplantation, or pediatric liver transplantation.
  • ABO-incompatible liver transplantation.
  • Incomplete clinical information.
  • Difficulty in follow-up.

Treatment and study plan

BCAA Nutritional Intervention

Dietary Supplement

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).

Muscle Rehabilitation Training

Behavioral

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)

Standard Nutritional Therapy

Dietary Supplement

Standard Nutritional Therapy

Primary outcomes

  1. 2-year overall survival

    Time frame: 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 outcomes

  1. Muscle mass

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zuyuan Lin

CONTACT

[email protected]

+8613606536446

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation: a Clinical Multicenter Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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