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NCT07467512Toboroz

Exercise for an Aging Liver (EXALIVER)

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 26.

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Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
40 (tervezett)
Első benyújtás
2026. febr. 3.
Kezdés
2026. márc. 1.
Elsődleges befejezés
2027. jún.
Fő szponzor
Consorcio Centro de Investigación Biomédica en Red (CIBER)
NCT-szám
NCT07467512

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 40
  • 2026. márc. 1. és az elsődleges befejezés (2027. jún.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Recent or planned major surgery, as well as anticancer therapies.
  • Regular use of medication or compounds that may affect study outcomes based on research staff criteria.

Más betegség

  • 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.

Egyéb

  • 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.
  • 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.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Hospital General Universitario Gregorio MarañónMadridSpanyolországToboroz

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