Nutrition and Exercise Prehabilitation in Patients Awaiting Liver Transplantation

Официальное название

Evaluation of Protein Distribution Optimization With Exercise Regimen on Nutritional Status, Body Composition and Functional Status in Patients Awaiting Liver Transplantation: The POWER-LT Randomized Clinical Trial

Обзор

This study aims to evaluate the effects of a diet with even protein distribution plus exercise (Group A) versus a diet with skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C) on nutritional status, body composition and functional status in patients awaiting liver transplantation.

Подробное описание

Malnutrition and sarcopenia affect many patients awaiting liver transplantation and is associated with reduced quality of life and increased mortality. According to the current European Society for Clinical Nutrition and Metabolism (ESPEN) and European Association for the Study of the Liver (EASL) guidelines, a target of 1.2-1.5 g protein per kg body weight daily is recommended for patients with decompensated liver cirrhosis. While evidence supports that even protein distribution enhances muscle protein synthesis in healthy adults, specific protein timing recommendations are lacking for patients with end-stage liver disease.

Therefore, this randomized controlled trial aims to investigate the effects of a 12-week diet with even protein distribution plus exercise (Group A) versus skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C), primarily on nutritional status, body composition and functional status, and secondarily on anthropometric measurements, laboratory parameters, quality of life, disease severity, complications and mortality in liver transplant candidates. Moreover, late postoperative parameters, including length of hospital stay, length of intensive care unit stay, duration of mechanical ventilation, postoperative complications, hospital readmissions, reoperations and mortality will be examined for those who undergo transplantation.

Вмешательства

• Поведенческое Diet with even protein distribution plus exercise program
  Diet of 1.2-1.5 g protein/kg dry body weight/day, equally divided (33.3% at 3 main meals) \| Exercise program: 3 days/week aerobic and 2 days/week resistance \| Duration: 12 weeks
• Поведенческое Diet with skewed protein distribution plus exercise program
  Diet of 1.2-1.5 g protein/kg dry body weight/day, unequally divided (10.0% at breakfast, 60.0% at lunch, 30.0% at dinner) \| Exercise program: 3 days/week aerobic and 2 days/week resistance \| Duration: 12 weeks
• Поведенческое Standard dietary and physical activity advice
  Standard dietary and physical activity advice \| Duration: 12 weeks

Первичные конечные точки

• Changes in Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition [Срок оценки: Baseline, 12 weeks]
• Changes in Computed Tomography (CT)-derived muscle mass [Срок оценки: Baseline, 12 weeks]
• Changes in handgrip strength (kg) [Срок оценки: Baseline, 12 weeks]
• Changes in Short Physical Performance Battery (SPPB) score [Срок оценки: Baseline, 12 weeks]
• Changes in Liver Frailty Index [Срок оценки: Baseline, 12 weeks]
• Changes in European Working Group on Sarcopenia in Older People 2 (EWGSOP2)-derived sarcopenia [Срок оценки: Baseline, 12 weeks]

Вторичные конечные точки (12)

• Nutritional Risk Screening-2002 (NRS-2002)-derived nutritional risk [Срок оценки: Baseline]
• Malnutrition Screening Tool (MST)-derived nutritional risk [Срок оценки: Baseline]
• Malnutrition Universal Screening Tool (MUST)-derived nutritional risk [Срок оценки: Baseline]
• Short Nutritional Assessment Questionnaire (SNAQ)-derived nutritional risk [Срок оценки: Baseline]
• Mini Nutritional Assessment-Short Form (MNA-SF)-derived nutritional status [Срок оценки: Baseline]
• Nutritional Risk Index (NRI)-derived nutritional risk [Срок оценки: Baseline]
• Prognostic Nutritional Index (PNI)-derived nutritional status [Срок оценки: Baseline]
• Controlling Nutritional Status (CONUT)-derived nutritional status [Срок оценки: Baseline]
• Liver Disease Undernutrition Screening Tool (LDUST)-derived nutritional risk [Срок оценки: Baseline]
• Royal Free Hospital-Nutritional Prioritizing Tool (RHT-NPT)-derived nutritional status [Срок оценки: Baseline]
• Dual-Energy X-ray Absorptiometry (DEXA)-derived muscle mass [Срок оценки: Baseline]
• Food Frequency Questionnaire (FFQ)-derived dietary habits [Срок оценки: Baseline]

Критерии участия

Критерии включения

• End-stage liver disease, diagnosed by transient elastography (FibroScan) or imaging-based evaluation with compatible clinical picture
• Referred for liver transplantation and evaluated to have a high likelihood of being listed, according to primary hepatologist assessment, or already listed for liver transplantation
• No prior formal dietary advice

Критерии исключения

• Age < 18 years old
• Estimated waiting time for liver transplantation < 3 months
• Estimated life expectancy < 3 months
• Chronic kidney disease requiring protein restriction
• Exercise contraindicated (e.g., active or recent variceal bleeding, severe grade of hepatic encephalopathy, refractory ascites, etc.)
• Unstable or severe psychiatric disorder
• Pregnancy or lactation
• Inability to provide written informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Греция · 2 центра

• Laiko General Hospital of Athens — Athens
• Agricultural University of Athens — Athens

Идентификаторы

NCT: NCT07561138 · 113/05.12.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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