Different Exercise Modalities in the Treatment of NAFLD and Their Impact on Myokines

Yeditepe University

Status: Enrolling

Conditions: Fatty Liver; Nonalcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; NAFLD

Treatments: Other: Exercise; Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT06257732

TBTK-MK-2022

Details and patient eligibility

About

The goal of this 12-week clinical trial is to investigate the effectiveness of different exercise types in treating Non-Alcoholic Fatty Liver Disease (NAFLD) and to explore their impact on myokine levels associated with lipid metabolism. The main questions it aims to answer are:

1. How does the type and dose of exercise affect the treatment of NAFLD?
2. What is the influence of exercise interventions in NAFLD treatment on myokine levels related to lipid metabolism?
3. How does motivational interviewing contribute to lifestyle modification in the treatment of NAFLD?

Participants in this study will engage in assigned exercise routines randomly, including HIIT, resistance training, or FATmax exercises. Additionally, motivational interviewing techniques will be employed to assess their impact on lifestyle changes. Researchers will compare the outcomes among the different exercise groups, along with a control group receiving only standard care for NAFLD. This comparison aims to determine the respective effects of these interventions on both NAFLD and associated myokine levels.

Enrollment: 144 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have received a diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD)
• Age between 25 and 50 years old
• Use of smartphone
• Fall into category A or B according to the American Heart Association Risk Assessment Criteria

Exclusion criteria

• Viral hepatitis
• Excessive alcohol consumption (more than 30 grams per day for men and more than 20 grams per day for women)
• Use of specific medications: amiodarone, corticosteroids, methotrexate, tamoxifen, synthetic estrogen, valproic acid, intravenous tetracycline, and highly active antiretroviral drugs
• Presence of accompanying chronic diseases such as Wilson's disease, hemochromatosis, and celiac disease
• Liver storage diseases
• Cancer
• Cirrhosis
• Advanced changes in liver ultrasonography evaluations, such as fibrosis
• Presence of other chronic diseases (kidney failure, heart failure, atherosclerotic heart disease, hypertension, arrhythmia disorders)
• BMI greater than 40 kg/m²
• History of surgery or trauma in the last 6 months
• Orthopedic and/or neurological impairment
• Health problems that may hinder participation in the exercise program
• Regular and continuous participation in sports or exercise at least 3 times a week for the past 3 years
• Family history of coronary artery disease (coronary artery disease before the age of 45 in male first-degree relatives and other male relatives, or before the age of 65 in female first-degree relatives and other female relatives)
• Presence of specific symptoms during medical history or physical examination: chest pain radiating to the neck, jaw, or arm, shortness of breath during rest or physical activity, dizziness, fainting, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, palpitations or tachycardia, intermittent claudication, heart murmur, unexplained excessive fatigue
• Fall into category C or D according to the American Heart Association Risk Assessment Criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

144 participants in 7 patient groups

Control Group

No Intervention group

Description:

This group will consist of individuals with liver fat accumulation under standard care and no exercise intervention will be implemented.

Fatmax Exercise Group

Experimental group

Description:

Individuals with liver fat accumulation under standard care will have their Fatmax values calculated and an exercise prescription will be designed accordingly.

Treatment:

Other: Exercise

Fatmax Exercise and Motivational Interviewing Group

Experimental group

Description:

In addition to the prescription of Fatmax exercise for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied.

Treatment:

Behavioral: Motivational Interviewing

Other: Exercise

HIIT Group

Experimental group

Description:

Individuals with liver fat accumulation under standard care will be provided with a High-Intensity Interval Training (HIIT) exercise prescription.

Treatment:

Other: Exercise

HIIT and Motivational Interviewing Group

Experimental group

Description:

In addition to formulating a High-Intensity Interval Training (HIIT) exercise prescription for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied.

Treatment:

Behavioral: Motivational Interviewing

Other: Exercise

Resistance Exercise Group

Experimental group

Description:

Individuals with liver fat accumulation under standard care will be provided with a resistance exercise prescription.

Treatment:

Other: Exercise

Resistance Exercise and Motivational Interviewing Group

Experimental group

Description:

In addition to formulating a resistance exercise prescription for individuals under standard care with liver fat accumulation, motivational interviewing principles will be applied.

Treatment:

Behavioral: Motivational Interviewing

Other: Exercise