Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis (RENACE)

April 28, 2026 updated by: Sergio Martinez-Huenchullan, Universidad San Sebastián

RENACE Study: Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5090000
        • Recruiting
        • Centro de Estudios Cientificos
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.
Experimental: High-intensity interval training group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance
Time Frame: This will be measured at week 0 and week 8
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
Time Frame: This will be measured at week 0 and week 8 of the study.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
KLK7 and plasmatic kallikrein
Time Frame: This will be measured at week 0 and week 8 of the study
These proteins will be measured before and after the study in plasma samples of the participants
This will be measured at week 0 and week 8 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad San Sebastián

Investigators

  • Principal Investigator: Sergio Martínez Huenchullán, PhD, Universidad San Sebastián

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/2026 (Other Identifier: Comitè d'Ètica i Investigació amb Medicaments)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Considering that the investigators will collect personal information of each participant, for Ethical reasons, the investigators will share only group data, such as means and standard deviation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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