Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With NAFLD
Primary Purpose
Nonalcoholic Fatty Liver Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease focused on measuring Aerobic Exercise, Whole Body Vibration Therapy
Eligibility Criteria
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
Sites / Locations
- Marmara University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Profile of liver enzymes
Serum liver enzymes ALT, AST, GGT, ALP will be recorded.
Full Information
NCT ID
NCT03461562
First Posted
February 27, 2018
Last Updated
August 3, 2018
Sponsor
Okan University
Collaborators
Marmara University, Medipol University
1. Study Identification
Unique Protocol Identification Number
NCT03461562
Brief Title
Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With NAFLD
Official Title
Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With Nonalcholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University
Collaborators
Marmara University, Medipol University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease
Keywords
Aerobic Exercise, Whole Body Vibration Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Other Intervention Name(s)
Whole Body Vibration Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
FibroScan
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Profile of liver enzymes
Description
Serum liver enzymes ALT, AST, GGT, ALP will be recorded.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Body composition
Description
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
Time Frame
8 weeks
Title
Cardiopulmonary exercise testing
Description
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
Time Frame
8 weeks
Title
Body Fat Percentage
Description
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
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Mutluay, Professor
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
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Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With NAFLD
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