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NCT07467512

Exercise for an Aging Liver (EXALIVER)

Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03

Completion Date

2027-10

Last Updated

2026-03-12

Healthy Volunteers

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease MASH - Metabolic Dysfunction-Associated Steatohepatitis Liver Fibrosis/NASH

Interventions

BEHAVIORAL

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) program to achieve a minimum of 135 minutes per week.

BEHAVIORAL

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.

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.

Locations (1)

Hospital General Universitario Gregorio Marañon

Madrid, Spain