Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis

NCT07552727 | Recruiting DMC

• 1 other identifier: 15/2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD); Metabolic Adaptation to High-Intensity Interval Training

Keywords

Exercise; Liver; Obesity

Outcome Measures

Primary Outcomes (2)

• Insulin resistance

  This will be measured through the calculation of the HOMA-IR before and after the study.

  This will be measured at week 0 and week 8

• Liver steatosis and fibrosis

  This will be measured through FibroScan before and after the exercise

  This will be measured at week 0 and week 8 of the study.

Secondary Outcomes (1)

• KLK7 and plasmatic kallikrein

  This will be measured at week 0 and week 8 of the study

Study Arms (2)

Control

NO INTERVENTION

No intervention. This group will receive a one-session councelling regarding the benefits of physical activity and nutrition in the management of fatty liver disease.

High-intensity interval training group

EXPERIMENTAL

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.

Behavioral: High-intensity interval training

Interventions

High-intensity interval training BEHAVIORAL

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.

High-intensity interval training group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 59 years from the Los Ríos Region
• Overweight or obesity (BMI \>25 kg/m²)
• Diagnosis of a chronic noncommunicable disease such as insulin resistance, and type 2 diabetes
• Fit to perform physical activity/exercise
• Exercise readiness will be confirmed using the PAR-Q+ questionnaire

You may not qualify if:

• Excessive alcohol consumption
• Liver diseases of other etiologies
• Musculoskeletal and/or cardiovascular conditions that contraindicate exercise - Inability to attend in-person exercise sessions, or pregnancy

Sponsors & Collaborators

• Universidad San Sebastián: lead

Study Sites (1)

Centro de Estudios Cientificos

Valdivia, Los Ríos Region, 5090000, Chile

RECRUITING

MeSH Terms

Conditions

Motor Activity; Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sergio Martínez Huenchullán, PhD

  Universidad San Sebastián

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Martinez-Huenchullan, PhD

CONTACT

56962859896; sergio.martinez@uss.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)