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

NCT ID: NCT06257732

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2024-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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NAFLD Nonalcoholic Fatty Liver Disease Fatty Liver, Nonalcoholic Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Fatmax Exercise Group

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.

Fatmax Exercise and Motivational Interviewing Group

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.

Motivational Interviewing

Intervention Type BEHAVIORAL

Motivational Interviewing will be employed as a counseling technique to elicit behavior change by fostering collaborative and empathetic conversations, enhancing motivation for positive lifestyle modifications in individuals with liver fat accumulation.

HIIT Group

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.

HIIT and Motivational Interviewing Group

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.

Motivational Interviewing

Intervention Type BEHAVIORAL

Motivational Interviewing will be employed as a counseling technique to elicit behavior change by fostering collaborative and empathetic conversations, enhancing motivation for positive lifestyle modifications in individuals with liver fat accumulation.

Resistance Exercise Group

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.

Resistance Exercise and Motivational Interviewing Group

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

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.

Motivational Interviewing

Intervention Type BEHAVIORAL

Motivational Interviewing will be employed as a counseling technique to elicit behavior change by fostering collaborative and empathetic conversations, enhancing motivation for positive lifestyle modifications in individuals with liver fat accumulation.

Interventions

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Exercise

The exercise interventions in this study include High-Intensity Interval Training (HIIT), involving brief bursts of intense exercise; Resistance Exercise, focusing on strength and muscle endurance; and Fatmax Exercise, tailored to optimize fat oxidation during aerobic activity.

Intervention Type OTHER

Motivational Interviewing

Motivational Interviewing will be employed as a counseling technique to elicit behavior change by fostering collaborative and empathetic conversations, enhancing motivation for positive lifestyle modifications in individuals with liver fat accumulation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Yeditepe University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yeditepe University

Istanbul, Ataşehir, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehtap Kaçar, MD, PhD, Prof

Role: CONTACT

+90 (216) 578 00 00 ext. 1419

Meltem Yalçın Oğuz, MSc, Pt

Role: CONTACT

+90 (216) 578 00 00 ext. 1533

Facility Contacts

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Meltem Yalçın Oğuz, MSc, Pt

Role: primary

+90 (216) 578 00 00 ext. 1533

Burçin Tuvana Us, MD

Role: backup

+90 (216) 578 00 00 ext. 1533

Other Identifiers

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TBTK-MK-2022

Identifier Type: -

Identifier Source: org_study_id

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