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Clinical Trials/NCT06257732
NCT06257732
Recruiting
Not Applicable

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

Yeditepe University1 site in 1 country144 target enrollmentJanuary 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
NAFLD
Sponsor
Yeditepe University
Enrollment
144
Locations
1
Primary Endpoint
Change in the liver steatosis grade
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2024
End Date
October 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

Change in the liver steatosis grade

Time Frame: 12-week

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.

Secondary Outcomes

  • ALT(12-week)
  • LDL(12-week)
  • CRP(12-week)
  • Changes in body mass index(12-week)
  • GGT(12-week)
  • Free fatty acids(12-week)
  • Changes in The 5 Times Sit-to-Stand Test results(12-week)
  • Changes in Single Leg Standing Test results(12-week)
  • Changes in the serum levels of myokines(12-week)
  • ESR(12-week)
  • Changes in body weight(12-week)
  • AST(12-week)
  • HDL(12-week)
  • Total cholesterol(12-week)
  • Changes in lean body mass(12-week)
  • Changes in body fat percentage(12-week)
  • Changes in peak oxygen consumption(12-week)
  • Changes in peak heart rate(12-week)
  • Triglycerides(12-week)
  • Changes in waist-to-hip ratio(12-week)
  • Changes in muscle strength analysis results(12-week)
  • Changes in FATmax levels(12-week)
  • Changes in Healthy Lifestyle Habits Scale II scores(12-week)
  • Changes in anaerobic threshold(12-week)
  • Changes in basal metabolic rate(12-week)
  • Changes in Short Form Survey (SF-36) scores(12-week)
  • Changes in Beck Depression Scale scores(12-week)
  • Changes in Pittsburgh Sleep Quality Index scores(12-week)

Study Sites (1)

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