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

NCT03461562 | Completed DMC

• 1 other identifier: MEDIPOL UNIVERSITY
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

Aerobic Exercise; Whole Body Vibration Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Profile of liver enzymes

  8 weeks

Other Outcomes (3)

• Body composition

  8 weeks

• Cardiopulmonary exercise testing

  8 weeks

• Body Fat Percentage

  8 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Other: Aerobic Exercise

Control

ACTIVE COMPARATOR

Other: Aerobic Exercise

Interventions

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.

Also known as: Whole Body Vibration Therapy

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Okan University: lead
• Marmara University: collaborator
• Medipol University: collaborator

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fatma Mutluay, Professor

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 12, 2018
• Study Start: January 5, 2018
• Primary Completion: June 30, 2018
• Study Completion: August 1, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-08

Locations

TU (1)