CClinicalTrials.gg
Not yet recruitingNCT06591507Updated Sep 19, 2024

Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation

An interventional study of BCAA Nutritional Intervention and Muscle Rehabilitation Training in Liver Transplantation and Sarcopenia, sponsored by Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Zhejiang University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Liver Transplantation
  • Sarcopenia

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Keywords

  • Liver transplantation
  • Sarcopenia
  • Branched-chain amino acids
  • Muscle rehabilitation
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In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 750 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    Preoperative and Postoperative BCAA Nutritional Intervention

    Dietary Supplement: BCAA Nutritional Intervention

  • Experimental
    Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation

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

  • Experimental
    Postoperative BCAA Nutritional Intervention

    Dietary Supplement: BCAA Nutritional Intervention

  • Experimental
    Postoperative Muscle Rehabilitation

    Behavioral: Muscle Rehabilitation Training

  • Placebo comparator
    Standard Nutritional Therapy

    Dietary Supplement: Standard Nutritional Therapy

Interventions

  • Dietary supplementBCAA 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).

  • BehavioralMuscle 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)

  • Dietary supplementStandard Nutritional Therapy

    Standard Nutritional Therapy

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What researchers measure

Primary outcomes

  1. 2-year overall survival

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

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

Secondary outcomes

  1. Muscle mass

    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.

    Time frame: From enrollment to the end of treatment at 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06591507
Lead sponsor
Zhejiang University
Responsible party
Xiao Xu (Professor, Zhejiang University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 19, 2024

Study contacts

Zuyuan Lin
Contact
3130102029@zju.edu.cn
+8613606536446

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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