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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461562
• Other study ID #: MEDIPOL UNIVERSITY
• Status: Completed
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 1, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Okan University	Marmara University, Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	FibroScan	In 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	Profile of liver enzymes	Serum liver enzymes ALT, AST, GGT, ALP will be recorded.	8 weeks