Exercise for an Aging Liver (EXALIVER)

Официальное название

Evaluation of the Impact of Physical Exercise on Metabolic Dysfunction-associated Steatotic Liver Disease in the Elderly

Обзор

The goal of this clinical trial is to learn how physical exercise affects liver health in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) or at-risk metabolic dysfunction-associated steatohepatitis (MASH); comparing responses between middle-aged adults (40-60 years old) and older adults (70 years and older) of any sex, as well as between participants with low-risk MASLD and high-risk MASH. The main question it aims to answer is: Could an exercise program reduce liver fat, inflammation and fibrosis, regardless of age and disease severity? Researchers will compare 4 different groups: A) older adults with at risk MASH who will exercise B) middle-aged people with at risk MASH who will exercise C) middle-aged people with low-risk MASLD who will exercise D) middle-aged people with low-risk MASLD who will not exercise, receiving usual care. Participants in the exercise groups will take part in a supervised 12-week exercise program that includes both strength and aerobic training, completed twice a week. All participants, including those receiving usual care, will have health asssessments before and after the 12-week period to measure changes in liver health.

Вмешательства

• Поведенческое Exercise
  The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion \>7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at \>85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking
• Поведенческое Usual Care
  Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.

Первичные конечные точки

• Change in hepatic fat content [Срок оценки: Change from baseline to 12 weeks]
• Change in liver inflammation and fibrosis [Срок оценки: Change from baseline to 12 weeks]
• Change in liver stiffness [Срок оценки: Change from baseline to 12 weeks.]

Вторичные конечные точки (12)

• Change in Enhanced Liver Fibrosis (ELF) Score [Срок оценки: Change from baseline to 12 weeks]
• Change in Pro-C3 serum levels [Срок оценки: Change from baseline to 12 weeks]
• Change in NIS4 serum biomarker of liver fibrosis [Срок оценки: Change from baseline to 12 weeks]
• Change in Metabolomics Advanced Steatohepatitis Fibrosis Score (MASEF) [Срок оценки: Change from baseline to 12 weeks]
• Change in visceral adipose tissue [Срок оценки: Change from baseline to 12 weeks]
• Change in pancreatic fat content [Срок оценки: Change from baseline to 12 weeks]
• Change in abdominal subcutaneous adipose tissue [Срок оценки: Change from baseline to 12 weeks]
• Change in abdominal intermuscular fat content [Срок оценки: Change from baseline to 12 weeks]
• Change in abdominal intramuscular fat content [Срок оценки: Change from baseline to 12 weeks]
• Change in abdominal skeletal muscle tissue [Срок оценки: Change from baseline to 12 weeks]
• Change in values of fasting glucose [Срок оценки: Change from baseline to 12 weeks]
• Change in values of HbA1c [Срок оценки: Change from baseline to 12 weeks]

Критерии участия

Критерии включения

• Middle-aged adults (40 to 60 years old) and older adults (aged 70 years or older)
• People diagnosed with Metabolic Disfunction-Associated Steatotic Liver Disease (MASLD); defined as the presence of hepatic steatosis (≥5% fat content) in conjunction with at least one cardiometabolic risk factor (overweight or obesity, dysglycaemia or Type II diabetes, elevated plasma triglycerides, reduced HDL-cholesterol or high blood preassure) with no other discernable cause.
• People diagnosed with at-risk Metabolic Disfunction-Associated SteatoHepatitis (MASH) according to the following criteria: I) a positive liver biopsy (NAS score ≥ 4 points (with at least one point in each of the components of the score: steatosis, lobular inflammation and ballooning, AND significant (F2) or advanced (F3) fibrosis), or II) a FAST score >0.65.

Критерии исключения

• Descompensated cirrhosis or end-stage liver disease.
• Other causes of liver disease, such as alcohol abuse or drug-induced, virus-related, or hereditary disease.
• History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which exercise is absolute contraindicated.
• Recent or planned major surgery, as well as anticancer therapies.
• Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate/vigorous intensity).
• Body weight instability. Participants must have maintained the body weight registered at screening visit (tolerance: 5%) for more than 3 months.
• Regular use of medication or compounds that may affect study outcomes based on research staff criteria.
• Pregnancy and lactation or planned pregnancy (within the study period).
• Frequent travel over time zones during the study period.
• Fear of needles and claustrophobia to magnetic resonance imaging (MRI).
• Low physical function (ie, ambulation dependency)
• Being unable to understand and to accept the instructions or the study objectives and protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital General Universitario Gregorio Marañon — Madrid

Идентификаторы

NCT: NCT07467512 · AG24_13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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