Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation

NCT06591507 | Not Yet Recruiting DMC

• 1 other identifier: CT2024-ZJU-RCT1
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Transplantation; Sarcopenia

Keywords

Liver transplantation; Sarcopenia; Branched-chain amino acids; Muscle rehabilitation

Outcome Measures

Primary Outcomes (1)

• 2-year overall survival

  At the 2-year mark, record the survival status of each patient (alive or deceased).

  From enrollment to the end of follow-up at 2 years

Secondary Outcomes (1)

• Muscle mass

  From enrollment to the end of treatment at 6 months

Study Arms (5)

Preoperative and Postoperative BCAA Nutritional Intervention

EXPERIMENTAL

Dietary Supplement: BCAA Nutritional Intervention

Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation

EXPERIMENTAL

Dietary Supplement: BCAA Nutritional Intervention; Behavioral: Muscle Rehabilitation Training

Postoperative BCAA Nutritional Intervention

EXPERIMENTAL

Dietary Supplement: BCAA Nutritional Intervention

Postoperative Muscle Rehabilitation

EXPERIMENTAL

Behavioral: Muscle Rehabilitation Training

Standard Nutritional Therapy

PLACEBO COMPARATOR

Dietary Supplement: Standard Nutritional Therapy

Interventions

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).

Postoperative BCAA Nutritional Intervention; Preoperative and Postoperative BCAA Nutritional Intervention; Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation

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)

Postoperative Muscle Rehabilitation; Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation

Standard Nutritional Therapy DIETARY_SUPPLEMENT

Standard Nutritional Therapy

Standard Nutritional Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Zuyuan Lin

CONTACT

+8613606536446; 3130102029@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09