Nonalcoholic Fatty Liver DiseaseNCT03461562
Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With NAFLD
A study testing Aerobic Exercise in people with Nonalcoholic Fatty Liver Disease, run by Okan University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2018to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Aerobic Exercise
- Keywords
- Aerobic Exercise, Whole Body Vibration Therapy
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Also called Whole Body Vibration Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: Aerobic Exercise |
| Control | Active comparator | Not described Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
Profile of liver enzymes
Serum liver enzymes ALT, AST, GGT, ALP will be recorded.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start5 Jan 2018
- Primary completion30 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University, Medipol University
- Responsible party
- Principal investigator, Tülay Çevik, Okan University
- Investigators
- Fatma Mutluay, Professor, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461562
- Sponsor's protocol ID
- MEDIPOL UNIVERSITY
- Status last verified
- Aug 2018
- First submitted
- 27 Feb 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With Nonalcholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03461562
- Acronym / sponsor ID
- MEDIPOL UNIVERSITY
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Aerobic Exercise, Whole Body Vibration Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Marmara University, Medipol University
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Aerobic Exercise |
| Control | Active comparator | Other: Aerobic Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnancy
- Chronic inflammatory process
- Rheumatic disease
- Cognitive disorders
- Obstacles to achieve physical performance tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAlso: Whole Body Vibration TherapyAerobic 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 | Control, Experimental |
Primary outcome
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.
1 secondary outcome
Profile of liver enzymes
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Mutluay, Professor study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Nonalcoholic Fatty Liver Disease, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FibroScan (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.