Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis
NCT07552727 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-05
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 Adaptation to High-Intensity Interval Training
- Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
Interventions
- 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.
Sponsors & Collaborators
-
Universidad San Sebastián
lead OTHER
Principal Investigators
-
Sergio Martínez Huenchullán, PhD · Universidad San Sebastián
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-13
- Primary Completion
- 2026-12-31
- Completion
- 2027-02-28
Countries
- Chile
Study Locations
More Related Trials
-
Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis
NCT06195943 ·Status: COMPLETED ·Phase: NA
-
A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3
NCT05461105 ·Status: COMPLETED ·Phase: PHASE2
-
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
NCT05737433 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment
NCT01987310 ·Status: WITHDRAWN ·Phase: NA
-
Efficacy of N-Acetylcysteine in Improving/Normalizing ALT & AST in Patients of NAFLD
NCT05576428 ·Status: UNKNOWN ·Phase: NA
-
Ambulatory Liver Fat Monitoring in Patients With Non-alcoholic Fatty Liver Disease
NCT05754385 ·Status: COMPLETED ·Phase: NA
-
Nutritional Intervention IN Nash NON-ALCOHOLIC (NAFLD).
NCT05946330 ·Status: UNKNOWN ·Phase: NA
-
Effect of In-Place Slow Jogging on Metabolic Dysfunction-Associated Steatotic Liver Disease
NCT06994234 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Use of EL-FIT App to Promote Physical Activity
NCT04604860 ·Status: COMPLETED ·Phase: NA
-
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
NCT06318169 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
NCT05402371 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Hepatitis B With Hepatic Steatosis Study
NCT02392598 ·Status: UNKNOWN
-
A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
NCT03776175 ·Status: COMPLETED ·Phase: PHASE2
-
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
NCT03587831 ·Status: RECRUITING ·Phase: NA
-
Pilot of Lifestyle Behavior Intervention for Non-Alcoholic Fatty Liver Disease
NCT05200585 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of NAFLD
NCT04450875 ·Status: COMPLETED ·Phase: NA
-
Clinical Performance of LIVERFASt Test Compared w/ Liver Biopsy in Patients w/ NAFLD.
NCT04579874 ·Status: COMPLETED ·Phase: NA
-
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
NCT05364684 ·Status: COMPLETED ·Phase: PHASE2
-
Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD
NCT06352177 ·Status: WITHDRAWN ·Phase: NA
-
Study to Evaluate the Effectiveness of Legalon®
NCT05051527 ·Status: COMPLETED
-
Assessment of Non-Invasive Testing in Major Liver-Related Outcomes
NCT06986447 ·Status: ENROLLING_BY_INVITATION
-
Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
NCT00913289 ·Status: TERMINATED ·Phase: PHASE1
-
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
NCT01062750 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
NCT05244720 ·Status: COMPLETED ·Phase: NA
-
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
NCT06138821 ·Status: RECRUITING ·Phase: NA