Exercise for an Aging Liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will enroll adults with MASLD or at-risk MASH and assign them to four groups to examine the effects of a structured exercise program versus usual care. Participants aged 40–60 or 70+, with MASLD or at-risk MASH, will undergo a supervised 12-week exercise regimen combining strength training and aerobic activity. The trial will compare responses between age groups (middle-aged vs older) and between low-risk MASLD and high-risk MASH to see if exercise can lessen liver fat, inflammation, and fibrosis. A non-exercise control group will receive usual care, allowing assessment of exercise effects on liver health outcomes. Outcomes focus on liver fat content, inflammatory markers, and fibrosis-related measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Hospital General Universitario Gregorio Marañon
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Jose Serra-Rexach, PhD
• Email: joseantonio.serra@salud.madrid.es
• Phone: +34915868835

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.