Different Exercise Modalities in the Treatment of NAFLD and Their Impact on Myokines
Investigation of Effectiveness of Different Exercise Types, and Their Therapeutic Effect Mechanisms and the Roles of Motivational Interview in the Treatment of Non-Alcoholic Fatty Liver Disease
1 other identifier
interventional
144
1 country
1
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2024
CompletedStudy Start
First participant enrolled
January 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2024
CompletedFebruary 26, 2024
January 1, 2024
8 months
January 5, 2024
February 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the liver steatosis grade
Changes in the level of liver fat accumulation in radiological abdominal ultrasonography (USG) will be observed. The difference between the values obtained at the beginning of the study and those measured after completing the program will be evaluated. Data collected at the beginning and end of the study will be compared.
12-week
Secondary Outcomes (28)
ALT
12-week
AST
12-week
GGT
12-week
Free fatty acids
12-week
Triglycerides
12-week
- +23 more secondary outcomes
Study Arms (7)
Control Group
NO INTERVENTIONThis group will consist of individuals with liver fat accumulation under standard care and no exercise intervention will be implemented.
Fatmax Exercise Group
EXPERIMENTALIndividuals with liver fat accumulation under standard care will have their Fatmax values calculated and an exercise prescription will be designed accordingly.
Fatmax Exercise and Motivational Interviewing Group
EXPERIMENTALIn addition to the prescription of Fatmax exercise for individuals with liver fat accumulation under standard care, motivational interviewing principles will be applied.
HIIT Group
EXPERIMENTALIndividuals with liver fat accumulation under standard care will be provided with a High-Intensity Interval Training (HIIT) exercise prescription.
HIIT and Motivational Interviewing Group
EXPERIMENTALIn 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.
Resistance Exercise Group
EXPERIMENTALIndividuals with liver fat accumulation under standard care will be provided with a resistance exercise prescription.
Resistance Exercise and Motivational Interviewing Group
EXPERIMENTALIn addition to formulating a resistance exercise prescription for individuals under standard care with liver fat accumulation, motivational interviewing principles will be applied.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yeditepe University
Istanbul, Ataşehir, 34755, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2024
First Posted
February 14, 2024
Study Start
January 5, 2024
Primary Completion
September 15, 2024
Study Completion
October 15, 2024
Last Updated
February 26, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share