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NCT Number: NCT03461562

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

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.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Other

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

Primary outcomes

  1. FibroScan

    Time frame: 8 weeks

    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 outcomes

  1. Profile of liver enzymes

    Time frame: 8 weeks

    Serum liver enzymes ALT, AST, GGT, ALP will be recorded.

Other outcomes

  1. Body composition

    Time frame: 8 weeks

    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

  2. Cardiopulmonary exercise testing

    Time frame: 8 weeks

    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

  3. Body Fat Percentage

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Okan University

Other

Collaborators

  • Marmara University
  • Medipol University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2018
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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