Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
All Genders
NCT07552727

Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis

Led by Universidad San Sebastián · Updated on 2026-05-05

30

Participants Needed

1

Research Sites

45 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study proposes a single-blind randomized clinical trial designed to evaluate the effects of high-intensity interval training (HIIT) on liver health in adults with overweight or obesity, while also assessing the usefulness of FibroScan as a tool for detecting and monitoring hepatic changes. The study is grounded in the idea that HIIT may improve liver status in individuals with metabolic dysfunction-associated steatotic liver disease, even in the absence of major weight loss, and that FibroScan could serve not only as a diagnostic method but also as a follow-up instrument during conservative treatment. The sample will include 30 adults from the Los Ríos Region, aged 18 to 59 years, with BMI \>25 kg/m² and chronic noncommunicable conditions such as dyslipidemia, diabetes, or hypertension, provided they are fit for exercise. Participants will be randomly assigned to either an intervention group (HIIT, n=15) or a non-trained control group (n=15). Recruitment will be community-based, using posters and social media, and eligibility will be screened with the PAR-Q+ questionnaire. Individuals with excessive alcohol intake, liver disease of other etiologies, pregnancy, or contraindications to exercise will be excluded. The HIIT intervention will last 8 weeks, with 2 to 3 sessions per week, each session lasting 30 minutes. The protocol consists of five 2.5-minute bouts at 80% of heart rate reserve, interspersed with 2.5-minute active recovery periods at 20% of heart rate reserve. The training will be supervised by a physical therapist experienced in cardiometabolic exercise prescription, and the control group will receive training after the study is completed for ethical reasons. Before and after the intervention, participants will undergo a comprehensive evaluation including blood sampling, anthropometry, body composition, and physical fitness assessment. Blood markers will include transaminases, lipid profile, glucose, and HbA1c. Liver health will be assessed by FibroScan through controlled attenuation parameter (CAP) for steatosis and liver stiffness for fibrosis. Additional variables such as waist circumference, muscle mass, fat mass, handgrip strength, and prior physical activity level will also be recorded. Statistically, the study will compare baseline differences between groups and evaluate pre-post changes after the intervention using parametric or nonparametric tests according to data distribution, along with correlation and multiple regression analyses. The expected outcome is that HIIT will improve liver-related parameters, and that FibroScan will be sensitive enough to detect these changes, supporting its value as a regional clinical tool for the identification and follow-up of hepatic steatosis and fibrosis in people with overweight or obesity.

CONDITIONS

Official Title

Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 59 years and living in the Los Ros Region
  • Overweight or obese with BMI over 25 kg/m8
  • Diagnosed with a chronic noncommunicable disease such as insulin resistance or type 2 diabetes
  • Fit and cleared to perform physical activity or exercise
  • Passed the PAR-Q+ questionnaire for exercise readiness
Not Eligible

You will not qualify if you...

  • Excessive alcohol consumption
  • Liver diseases caused by other factors
  • Musculoskeletal or cardiovascular conditions that make exercise unsafe
  • Unable to attend in-person exercise sessions
  • Pregnant women

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centro de Estudios Cientificos

Valdivia, Los Ríos Region, Chile, 5090000

Actively Recruiting

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Research Team

S

Sergio Martinez-Huenchullan, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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