Clinical trial NCT06257732: Different Exercise Modalities in the Treatment of NAFLD and Their Impact on Myokines
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
Nonalcoholic Fatty Liver Disease
Fatty Liver, Nonalcoholic
Fatty Liver
Keywords: Exercise
Myokine
HIIT
Fatmax Intensity
Resistance Exercise
Motivational Interviewing
NAFLD
Lead sponsor: Yeditepe University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-02-14
Enrollment: 144
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the liver steatosis grade
timeFrame: 12-week
Secondary outcomes:
measure: ALT
timeFrame: 12-week
measure: AST
timeFrame: 12-week
measure: GGT
timeFrame: 12-week
measure: Free fatty acids
timeFrame: 12-week
measure: Triglycerides
timeFrame: 12-week
measure: HDL
timeFrame: 12-week
measure: LDL
timeFrame: 12-week
measure: Total cholesterol
timeFrame: 12-week
measure: CRP
timeFrame: 12-week
measure: ESR
timeFrame: 12-week
measure: Changes in body weight
timeFrame: 12-week
measure: Changes in lean body mass
timeFrame: 12-week
measure: Changes in body fat percentage
timeFrame: 12-week
measure: Changes in body mass index
timeFrame: 12-week
measure: Changes in waist-to-hip ratio
timeFrame: 12-week
measure: Changes in peak oxygen consumption
timeFrame: 12-week
measure: Changes in peak heart rate
timeFrame: 12-week
measure: Changes in anaerobic threshold
timeFrame: 12-week
measure: Changes in basal metabolic rate
timeFrame: 12-week
measure: Changes in muscle strength analysis results
timeFrame: 12-week
measure: Changes in The 5 Times Sit-to-Stand Test results
timeFrame: 12-week
measure: Changes in Single Leg Standing Test results
timeFrame: 12-week
measure: Changes in FATmax levels
timeFrame: 12-week
measure: Changes in Healthy Lifestyle Habits Scale II scores
timeFrame: 12-week
measure: Changes in Short Form Survey (SF-36) scores
timeFrame: 12-week
measure: Changes in Beck Depression Scale scores
timeFrame: 12-week
measure: Changes in Pittsburgh Sleep Quality Index scores
timeFrame: 12-week
measure: Changes in the serum levels of myokines
timeFrame: 12-week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
state: Ataşehir
Study officials:
References: