Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With NAFLD

Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With Nonalcholic Fatty Liver Disease

Purpose of the study will investigate the effects of two different training programs on hepatic steatosis and physical fitness parameters. This trial is designed in a randomized controlled study plan and aerobic training (40 minutes) wil be combined with Whole Body Vibration Training (WBVT for 15 minutes) which is made up of a shorter time application. WBVT to be applied instead of the resistance exercises.

Study Overview

• Status: Completed
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Aerobic Exercise

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of NAFLD
• Age range of 18-65 years
• Participants who are not in an active exercise program
• Participants who are not on an active diet program

Exclusion Criteria:

• Pregnancy
• Chronic inflammatory process
• Rheumatic disease
• Cognitive disorders
• Obstacles to achieve physical performance tests
• Presence of other conditions that may cause liver steatosis
• Inability to do WBVT or Aerobic Exercises

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Other: Aerobic Exercise; Aerobic exercise wil be held for 40 minutes. Dynamic exercises will be accompanied by physiotherapist on the vibration platform for 15 minutes. Same excercises will be held stable platform (when the devices turned off) by control group for 15 minutes.; Other Names: Whole Body Vibration Therapy
Active Comparator: Control	Other: Aerobic Exercise; Aerobic exercise wil be held for 40 minutes. Dynamic exercises will be accompanied by physiotherapist on the vibration platform for 15 minutes. Same excercises will be held stable platform (when the devices turned off) by control group for 15 minutes.; Other Names: Whole Body Vibration Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FibroScan	İn the Fibroscan measurement session, the patient lying supine, the tip of the transducer is placed on the skin between the ribs over the right lobe of the liver. At least 10 validated measurements with a ratio of interquartile range (IQR) and median LSM of less than or equal to 30 percent are required for an interpretation of significant fibrosis or cirrhosis.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of liver enzymes	Serum liver enzymes ALT, AST, GGT, ALP will be recorded.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body mass index (BMI) will be calculated by dividing weight (kg) by height (m2). The BMI Categories will be done as follows: Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater	8 weeks
Cardiopulmonary exercise testing	Cardiopulmonary exercise testing (CPET) will be done.The goal of testing is to evaluate the physiologic response of the heart, lungs and muscles to an increase in physical stress. Cardiopulmonary exercise testing (CPET) with cycle ergometer. The following values will be calculated personally. Peak oxygen consumption Peak heart rate Metabolic equivalent Aerobic threshold Anaerobic threshold Heart rate reserve	8 weeks
Body Fat Percentage	Body Fat Percentage will be calculated skinfold measures using Jackson-Pollock measurement system. The Jackson-Pollack method for evaluating body fat percentage requires three skinfold measurements. For men, measurement sites are the chest, abdomen and thigh; for women, they consist of the thigh, triceps and suprailiac crest, or just above the top of the hip bone. Body Fat Percentage Formula will be use as follows: The formula for men is: 1.10938 - (0.0008267 x the sum of the chest, abdomen and thigh measurements in millimeters) + (0.0000016 x the square of the sum of the chest, abdomen and thigh measurements in millimeters) - (0.0002574 x age) = body density The formula for women, also known as the Jackson-Pollock-Ward formula, is: 1.0994921 - (0.0009929 x the sum of the triceps, thigh and suprailiac measurements) + (0.0000023 x the square of the sum of the triceps, thigh and suprailiac measurements) - (0.0001392 x age) = body density	8 weeks

Collaborators and Investigators

• Sponsor: Okan University
• Collaborators: Marmara University; Medipol University
• Investigators: Study Director: Fatma Mutluay, Professor, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Aerobic Exercise; Whole Body Vibration Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Medipol University (Registry Identifier: 10840098-604.01.01-E.10470)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No