Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation

NCT ID: NCT06591507

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Preoperative and Postoperative BCAA Nutritional Intervention

Group Type: EXPERIMENTAL

BCAA Nutritional Intervention

Intervention Type: 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).

Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation

Group Type: EXPERIMENTAL

BCAA Nutritional Intervention

Intervention Type: 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

Intervention Type: 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 BCAA Nutritional Intervention

Group Type: EXPERIMENTAL

BCAA Nutritional Intervention

Intervention Type: 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 Muscle Rehabilitation

Group Type: EXPERIMENTAL

Muscle Rehabilitation Training

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Standard Nutritional Therapy

Intervention Type: DIETARY_SUPPLEMENT

Standard Nutritional Therapy

Interventions

BCAA 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).

Intervention Type: DIETARY_SUPPLEMENT

Muscle 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)

Intervention Type: BEHAVIORAL

Standard Nutritional Therapy

Standard Nutritional Therapy

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Xiao Xu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zuyuan Lin

Role: CONTACT

3130102029@zju.edu.cn

+8613606536446

Other Identifiers

CT2024-ZJU-RCT1

Identifier Type: -

Identifier Source: org_study_id