Liver TransplantationNCT06591507
Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation
A study testing BCAA Nutritional Intervention, Muscle Rehabilitation Training and Standard Nutritional Therapy in people with Liver Transplantation and Sarcopenia, run by Zhejiang University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation, Sarcopenia
- What is being tested?
- BCAA Nutritional Intervention, Muscle Rehabilitation Training and Standard Nutritional Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation: a Clinical Multicenter Study
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
- Being tested
- BCAA Nutritional Intervention, Muscle Rehabilitation Training, Standard Nutritional Therapy
- Keywords
- Liver transplantation, Sarcopenia, Branched-chain amino acids, Muscle rehabilitation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAA Nutritional InterventionDietary 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 TrainingBehavioural
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 TherapyDietary supplement
Standard Nutritional Therapy
| Study group | Role | What they receive |
|---|---|---|
| Preoperative and Postoperative BCAA Nutritional Intervention | Experimental | Not described Receives: Dietary Supplement: BCAA Nutritional Intervention |
| Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation | Experimental | Not described Receives: Dietary Supplement: BCAA Nutritional Intervention; Behavioral: Muscle Rehabilitation Training |
| Postoperative BCAA Nutritional Intervention | Experimental | Not described Receives: Dietary Supplement: BCAA Nutritional Intervention |
| Postoperative Muscle Rehabilitation | Experimental | Not described Receives: Behavioral: Muscle Rehabilitation Training |
| Standard Nutritional Therapy | Placebo comparator | Not described Receives: Dietary Supplement: Standard Nutritional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival
At the 2-year mark, record the survival status of each patient (alive or deceased).
Measured: 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.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591507
- Sponsor's protocol ID
- CT2024-ZJU-RCT1
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation: a Clinical Multicenter Study
- ClinicalTrials.gov ID
- NCT06591507
- Acronym / sponsor ID
- CT2024-ZJU-RCT1
- Conditions
- Liver Transplantation, Sarcopenia
- Keywords
- Liver transplantation, Sarcopenia, Branched-chain amino acids, Muscle rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCAA Nutritional InterventionPatients 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). | Dietary supplement | Postoperative BCAA Nutritional Intervention, Preoperative and Postoperative BCAA Nutritional Intervention, Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation |
| Muscle Rehabilitation TrainingPhase 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) | Behavioural | Postoperative Muscle Rehabilitation, Preoperative and Postoperative BCAA Nutritional Intervention + Postoperative Muscle Rehabilitation |
| Standard Nutritional TherapyStandard Nutritional Therapy | Dietary supplement | Standard Nutritional Therapy |
Primary outcome
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).
1 secondary outcome
Muscle mass
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA Nutritional Intervention, Muscle Rehabilitation Training and Standard Nutritional Therapy in people with Liver Transplantation and Sarcopenia, run by Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zuyuan Lin (+8613606536446, 3130102029@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year overall survival (time frame: From enrollment to the end of follow-up at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.