Non-Alcoholic SteatohepatitisNCT05065593
The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis
A study testing resistance and aerobic exercise and physical activity recommendation in people with Non-Alcoholic Steatohepatitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The term non-alcoholic fatty liver disease (NAFLD) is used to describe a range of chronic liver diseases that range from steatosis to steatohepatitis, advanced fibrosis, cirrhosis, or excessive alcohol consumption or other causes of steatosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Steatohepatitis
- What is being tested?
- resistance and aerobic exercise and physical activity recommendation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2021to 30 Jan 2025
- 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
- Having been diagnosed with NASH according to the diagnostic criteria determined by the American Gastroenterology Society / Asia-Pacific Working Group,
- No history of hepatic decompensation such as hepatic encephalopathy or abdominal ascites,
- Not being obese according to the criteria of the World Health Organization (Body Mass Index (BMI) <30),
- HbA1c value <6.5%,
- No changes in blood pressure, hyperlipidemia drugs in the last 3 months,
- Absence of any mental disorder or exercise compliance problem that would prevent them from participating in the study.
- It was determined as being voluntary to participate in the study.
Who cannot join
- A history of liver disease other than NASH, such as acute or chronic viral hepatitis, autoimmune hepatitis,
- Alcohol consumption >30 g/day in men and >20 g/day in women,
- Having regular exercise habits,
- Presence of conditions where exercise is contraindicated, such as unstable ischemia, decompensated heart failure, arrhythmia that increases with exercise and cannot be controlled, severe aortic stenosis, hypertrophic cardiomyopathy,
- Having orthopedic problems that limit lower extremity movements such as previous cerebrovascular disease, neurological diseases that cause cognitive and motor loss such as Alzheimer's and Parkinson's, and endoprosthesis surgery in the last three months, permanent joint contracture,
- Regular use of food supplements,
- It was determined that he did not volunteer to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara
About this study
Official title: The Effect of Aerobic and Resistant Exercise Training on Hepatic Functions, Inflammatory Markers and Functional Capacity in Patients With Non-Alcoholic Steatohepatitis
The term non-alcoholic fatty liver disease (NAFLD) is used to describe a range of chronic liver diseases that range from steatosis to steatohepatitis, advanced fibrosis, cirrhosis, or excessive alcohol consumption or other causes of steatosis. In this spectrum, Non-Alcoholic Steatohepatitis (NASH), which defines liver damage accompanied by steatosis and inflammation (hepatitis), is one of the most common causes of chronic liver disease worldwide, especially in developed and developing countries, and is present in 15-35% of the general population. Individuals diagnosed with NASH primarily experience deterioration in liver functions, but patients are also affected in terms of vascular structures, immunopathological responses, functional and psychosocial conditions. It is seen that in addition to intrahepatic lipid content, inflammatory markers, liver enzymes, and liver functions, cardiopulmonary endurance, physical activity level, and muscle strength are also affected in these patients, so it is evaluated for the diagnosis and planning of the treatment of the disease. There is no drug with proven efficacy in the treatment of the disease. Since a significant proportion of NASH patients have obesity, Type II Diabetes Mellitus or dyslipidemia, the focus of treatment is to control risk factors or protect the liver from harmful factors such as TNFα. Therefore, the mainstay of treatment, for now, seems to be weight control with a lifestyle change, including regular exercise training and diet control. Exercise intervention is considered an essential component of NAFLD treatment, however; there are a limited number of published articles showing the effects of exercise training in the management of NASH. In addition, the physiological effect of exercise has still not been clarified because NASH is accompanied by metabolic problems such as obesity and T2DM. This study, it is aimed to bring innovation to the literature in understanding the physiological effects of exercise for this disease group by examining the effects of resistance exercise training in addition to aerobic exercise on intrahepatic lipid content, liver functions, inflammatory markers, muscle strength, functionality, and biopsychosocial status in individuals with NASH diagnosis who do not have an additional metabolic problem.
- Conditions
- Non-Alcoholic Steatohepatitis
- Being tested
- resistance and aerobic exercise, physical activity recommendation
- Keywords
- fibrosis, exercise, inflammation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance and aerobic exerciseOther
Resistive exercises allow loading the muscle under suitable conditions with various weights or resistances. In order to increase the level of physical fitness with the increase of muscle strength and bone mass in individuals, resistance exercises were preferred. Aerobic exercises, on the other hand, are a special type of exercise that develops both the musculoskeletal system and the cardiovascular system, which includes large muscle groups and should be performed for at least 20 minutes when the heart rate accelerates at certain rates. Aerobic exercise was preferred in order to increase cardiovascular endurance, accelerate fat burning and reduce fatigue.
physical activity recommendationOther
Patients will be informed about the importance of lifestyle change in disease management, walking training will be given to increase their physical activity level, and participants will be asked to follow a 45-minute walking program every day within their own means.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Training Group | Experimental | After completing all assessments, the intervention group will participate in face-to-face exercise training with a physiotherapist for 3 days for 4 months.
In the first week, patients will be taught body awareness; parameters of correct loading on the muscle will be explained and the limits of safe exercise will be drawn. At the beginning and end of all exercises, there will be short-term active stretching and relaxation exercises performed by the patient as a warm-up and cool-down period. In the first 4 weeks, it is planned to increase the physical fitness levels of individuals with progressive resistance exercises and to make them suitable for aerobic loading. For each patient, the PRE, resistance will be increased from 60% to 80% for as long as the person can. At the end of the 1st month, the time allocated to resistance exercise training will be reduced and until the end of the 4th month, an increasing intensity aerobic exercise training will be given on the stationary bike. Receives: Other: resistance and aerobic exercise |
| Home-Based Control Group | Active comparator | After the patients assigned to the control group are evaluated by the physiotherapist with field tests and scales for physical functions, the patients will be informed about the importance of lifestyle changes in disease management, gait training will be given to increase their physical activity level and participants will be asked to follow a 45-minute walking program every day within their own means. All patients in the control group will be followed up regularly and their activity levels will be questioned in interim evaluations by asking them to keep a weekly physical activity diary. Receives: Other: physical activity recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline intrahepatic lipid percentage
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver, developed in order to facilitate, by enriching, patient recruitment for clinical trials in NASH. The PDFF method is the most objective method for lipid measurement in the liver.
Measured: Change from baseline intrahepatic lipid percentage to 16th week
Change from baseline hepatic steatosis percentage
Magnetic Resonance Elastography (MRE) is a technology that combines MRI imaging with low-frequency vibrations to create a visual map (elastogram) that shows the stiffness of body tissues. Currently, MRE is used to detect stiffening of the liver caused by fibrosis and inflammation in chronic liver disease. In chronic liver disease, before reaching the stage of cirrhosis, while detecting fibrosis in the early stages, a tissue stiffness map called elastogram can be drawn. Because the waves can be visualized and analyzed deep in the liver, MRE can evaluate much larger amounts of the total liver than a liver biopsy and has been shown to have high diagnostic accuracy in studies.
Measured: Change from baseline steatosis percentage to 16th week
Change of liver function parameters level
Routine liver function test results including alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin, and bilirubin will be measured. All parameters will be recorded in IU/L.The ALT and AST tests measure enzymes that the liver releases in response to damage or disease. The albumin test measures how well the liver creates albumin, while the bilirubin test measures how well it disposes of bilirubin. ALP can be used to evaluate the bile duct system of the liver.
Measured: Change from baseline liver function parameters level to 16th week
Change of lipid panel
The lipid panel analysis contains total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides. All parameters will be recorded in mg/dL. Higher than normal cholesterol levels are associated with cardiovascular and metabolic diseases. Also, high total cholesterol LDL or triglyceride ratios are associated with NASH. Therefore, the lipid profile is evaluated to monitor NASH progression.
Measured: Change from baseline lipid panel values to 16th week
Secondary outcomes (12)
Evaluation of inflammatory markers
At the beginning of the study and at the end of the 4th month corresponding to the end of the treatment, the cytokine serum levels of all individuals will be measured by the specialist physician. These cytokines; The proinflammatory cytokine hsCRP, TNF α, which is one of the primary indicators of inflammation, has been determined as IL-6, which gives the earliest and most effective response to exercise and has an anti-inflammatory effect when released from the muscle, IL-10, which is an anti-inflammatory cytokine, and TGF β, which plays a central role in liver fibrogenesis. For measurement, 10 ml of blood sample for each cytokine will be taken from each patient, and the serum will be separated into a dry tube and stored frozen for further blood analysis at -20 °C until measurement.
Measured: 5 minutes, through study completion, an average of 16 weeks, change from baseline inflammatory marker status at 16 weeks.
Evaluation of aerobic capacity
Maximum Oxygen Consumption (VO2max) measurement is accepted as an easy, reliable and best indicator of aerobic capacity. Although a direct measuring device was considered for the study, considering the pandemic due to Covid-19, it was thought that even if it was disinfected for each patient, it would pose a risk due to contamination in the face mask of the device and the pipes that provide the air flow to the device. For this reason, aerobic capacity will be evaluated with the Increasing Speed Shuttle Walk Test (ISWT), which is one of the indirect measurement methods. This test is an exercise test in which walking between two cones 10 m apart at increasing speed for 12 minutes is counted as one sit-up for each 10-meter walk between the two cones. It is continued until the patient is unable to continue the test due to shortness of breath, the heart rate reaches 85% of the maximum expected heart rate, or completes the 12-minute test.
Measured: 12 minutes, through study completion, an average of 16 weeks, change from baseline aerobic capacity at 16 weeks.
Evaluation of physical activity level
It will be done with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). There are eight versions of the questionnaire in total, but the short form "last 7 days" will be used in this study. The short form (7 questions) provides information about the time spent in walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered a separate question. It is classified as low, medium, and high level by calculating the activity level of the person in terms of METs according to the duration, frequency, and intensity level of the movement. The Turkish version study was done by Sağlam et al.
Measured: 5 minutes, through study completion, an average of 16 weeks, change from baseline physical activity level at 16 weeks.
Evaluation of muscle strength
"Nicholas Manual Muscle Tester (Model 01165, Lafayette Instrument Company, Lafayette, Indiana, USA)" will be used for an objective evaluation. Since training will be given for large group muscles, muscle strength of hip, knee, shoulder and elbow flexors and extensors will be evaluated. The position of the dynamometer will be standardized for each measurement. The standard instruction, "push as hard as you can", will be given to the subject for each trial by applying a constant resistance for 3 to 5 seconds, directed perpendicular to the long axis of the measured extremity, in the test device to induce isometric muscle contraction. 3 repetitions will be done for each muscle group and the highest score will be recorded in kilograms (kg).
Measured: 10 minutes, through study completion, an average of 16 weeks, change from baseline fatique status at 16 weeks
Evaluation of fatigue
The Fatigue Severity Scale (FSS) will be used, the Turkish validity and reliability study of which was conducted by Armutlu et al. It is a self-report scale consisting of 9 items that evaluates the degree of fatigue severity in the last 1 week. According to a 7-point Likert scale for each item, the most appropriate one of the statements ranging from 7=strongly agree to 1=strongly disagree is marked by the patient. The scores obtained from each item are added together and the total value is divided by 9. 4.0 is used as the cut-off value for fatigue in studies.
Measured: 5 minutes, through study completion, an average of 16 weeks, change from baseline fatique status at 16 weeks
Evaluation of pain
The presence of pain of the participants will be questioned; If there is pain, it will be requested to be marked on the body diagram and its duration, localization, frequency, triggering factors, and whether it occurs during rest and activity will be recorded. In addition, using the Visual Analogue Scale (VAS), the patient will be asked to mark the severity of the pain on a 10-centimeter line, and it will be measured with a ruler and recorded out of 10. Pain intensity can take the lowest 0 and the highest 10 value. A higher score means worsening of pain.
Measured: 5 minutes, through study completion, an average of 16 weeks, change from baseline pain status at 16 weeks
Evaluation of quality of life
ts validity and reliability have been established in healthy individuals and in various disease groups, and the quality of life will be evaluated with the Short Form-36 (SF-36), the first Turkish validity and reliability of which was made by Koçyiğit et al. (46). General health perception, physical function, social function, pain, mental health, role difficulty due to physical reasons, role difficulty due to emotional reasons and vitality are 8 sub-parameters of SF-36 and it includes 11 questions consisting of 36 items. Each sub-parameter is scored between 0 and 100 points, and a high score indicates good health.
Measured: 10 minutes, through study completion, an average of 16 weeks, change from baseline quality of life at 16 weeks
Evaluation of anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) was developed to identify possible cases of anxiety disorder and depression in hospital clinics. The scope of use of the scale is not for diagnostic purposes, but to reveal depression and anxiety accompanying existing diseases. Turkish validity and reliability were performed by Aydemir et al. It is a 14-item scale consisting of the Anxiety subscale (HADS-A) and the Depression subscale (HADS-D), both of which contain seven items. The answer to each question is scored between 0-3 using a four-point Likert scale, and both sub-parameters can take a value between 0 and 21. Scores between 0 and 7 for each of the anxiety and depression parameters are considered "normal"; A score of 8 to 10 is considered a "probable case" and a score of 11 to 21 is considered a "probable case of anxiety/depression". These cutoff points were validated with a sensitivity and specificity of around 0.80 to clinical interviews.
Measured: 7 minutes, through study completion, an average of 16 weeks, change from baseline anxiety and depression status at 16 weeks
Evaluation of dynamic balance
The Timed Up and Go Test (TUG) will be used to evaluate balance and determine the risk of falling. The TUG test is an easy-to-use field test that has proven validity and reliability, and provides information about the dynamic balance of individuals and the risk of falling. For this test, the subject will be asked to get up from an armless chair and walk three meters, then turn around and sit down again. The elapsed time will be noted, the test will be repeated 3 times and the average time will be calculated.
Measured: 5 minutes, through study completion, an average of 16 weeks, change from baseline dynamic balance at 16 weeks
Evaluation of body mass index (BMI)
The height of the individuals will be measured with a Dikomsan brand stadiometer with the head in the Frankfort plane and the feet closed. Bodyweight (kg), body fat amount (kg), and lean body weight (kg) will be measured with Tanita BC 780 model body analyzer. Weight and height will be combined to report BMI in kg/m^2
Measured: 5 minutes, through study completion, an average of 16 weeks, change from baseline body mass index at 16 weeks
Evaluation of body fat percentage
Body fat percentage (%), and lean body weight ratio (%) will be measured with Tanita BC 780 model body analyzer.
Measured: 5 minutes, through study completion, an average of 16 weeks, change from baseline body fat percentage at 16 weeks
Daily calorie follow-up
The patients will be given a Low-Fat Diet Program, which is a routine nutritional treatment, at the first meeting. The food consumption records of the patients will be taken with a 24-hour retrospective reminder method during the dietitian visits. Food consumption records will be evaluated using the Nutrition Information Systems (BeBiS) Package Program.
Measured: 5 minutes, through study completion, an average of 16 weeks, change from baseline daily diet statusat 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start30 Sep 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Birgul Kumbaroglu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065593
- Sponsor's protocol ID
- KA- 21027
- Status last verified
- Jun 2024
- First submitted
- 13 Sep 2021
- Last updated
- 28 Jun 2024
- 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 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic and Resistant Exercise Training on Hepatic Functions, Inflammatory Markers and Functional Capacity in Patients With Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT05065593
- Acronym / sponsor ID
- KA- 21027
- Conditions
- Non-Alcoholic Steatohepatitis
- Keywords
- fibrosis, exercise, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 4 Oct 2021 (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.
The term non-alcoholic fatty liver disease (NAFLD) is used to describe a range of chronic liver diseases that range from steatosis to steatohepatitis, advanced fibrosis, cirrhosis, or excessive alcohol consumption or other causes of steatosis. In this spectrum, Non-Alcoholic Steatohepatitis (NASH), which defines liver damage accompanied by steatosis and inflammation (hepatitis), is one of the most common causes of chronic liver disease worldwide, especially in developed and developing countries, and is present in 15-35% of the general population. Individuals diagnosed with NASH primarily experience deterioration in liver functions, but patients are also affected in terms of vascular structures, immunopathological responses, functional and psychosocial conditions. It is seen that in addition to intrahepatic lipid content, inflammatory markers, liver enzymes, and liver functions, cardiopulmonary endurance, physical activity level, and muscle strength are also affected in these patients, so it is evaluated for the diagnosis and planning of the treatment of the disease. There is no drug with proven efficacy in the treatment of the disease. Since a significant proportion of NASH patients have obesity, Type II Diabetes Mellitus or dyslipidemia, the focus of treatment is to control risk factors or protect the liver from harmful factors such as TNFα. Therefore, the mainstay of treatment, for now, seems to be weight control with a lifestyle change, including regular exercise training and diet control. Exercise intervention is considered an essential component of NAFLD treatment, however; there are a limited number of published articles showing the effects of exercise training in the management of NASH. In addition, the physiological effect of exercise has still not been clarified because NASH is accompanied by metabolic problems such as obesity and T2DM. This study, it is aimed to bring innovation to the literature in understanding the physiological effects of exercise for this disease group by examining the effects of resistance exercise training in addition to aerobic exercise on intrahepatic lipid content, liver functions, inflammatory markers, muscle strength, functionality, and biopsychosocial status in individuals with NASH diagnosis who do not have an additional metabolic problem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Training Group | Experimental | Other: resistance and aerobic exerciseAfter completing all assessments, the intervention group will participate in face-to-face exercise training with a physiotherapist for 3 days for 4 months. In the first week, patients will be taught body awareness; parameters of correct loading on the muscle will be explained and the limits of safe exercise will be drawn. At the beginning and end of all exercises, there will be short-term active stretching and relaxation exercises performed by the patient as a warm-up and cool-down period. In the first 4 weeks, it is planned to increase the physical fitness levels of individuals with progressive resistance exercises and to make them suitable for aerobic loading. For each patient, the PRE, resistance will be increased from 60% to 80% for as long as the person can. At the end of the 1st month, the time allocated to resistance exercise training will be reduced and until the end of the 4th month, an increasing intensity aerobic exercise training will be given on the stationary bike. |
| Home-Based Control Group | Active comparator | Other: physical activity recommendationAfter the patients assigned to the control group are evaluated by the physiotherapist with field tests and scales for physical functions, the patients will be informed about the importance of lifestyle changes in disease management, gait training will be given to increase their physical activity level and participants will be asked to follow a 45-minute walking program every day within their own means. All patients in the control group will be followed up regularly and their activity levels will be questioned in interim evaluations by asking them to keep a weekly physical activity diary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having been diagnosed with NASH according to the diagnostic criteria determined by the American Gastroenterology Society / Asia-Pacific Working Group,
- No history of hepatic decompensation such as hepatic encephalopathy or abdominal ascites,
- Not being obese according to the criteria of the World Health Organization (Body Mass Index (BMI) <30),
- HbA1c value <6.5%,
- No changes in blood pressure, hyperlipidemia drugs in the last 3 months,
Key exclusion criteria (7 listed)
- A history of liver disease other than NASH, such as acute or chronic viral hepatitis, autoimmune hepatitis,
- Alcohol consumption >30 g/day in men and >20 g/day in women,
- Having regular exercise habits,
- Presence of conditions where exercise is contraindicated, such as unstable ischemia, decompensated heart failure, arrhythmia that increases with exercise and cannot be controlled, severe aortic stenosis, hypertrophic cardiomyopathy,
- Having orthopedic problems that limit lower extremity movements such as previous cerebrovascular disease, neurological diseases that cause cognitive and motor loss such as Alzheimer's and Parkinson's, and endoprosthesis surgery in the last three months, permanent joint contracture,
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 |
|---|---|---|
| resistance and aerobic exerciseResistive exercises allow loading the muscle under suitable conditions with various weights or resistances. In order to increase the level of physical fitness with the increase of muscle strength and bone mass in individuals, resistance exercises were preferred. Aerobic exercises, on the other hand, are a special type of exercise that develops both the musculoskeletal system and the cardiovascular system, which includes large muscle groups and should be performed for at least 20 minutes when the heart rate accelerates at certain rates. Aerobic exercise was preferred in order to increase cardiovascular endurance, accelerate fat burning and reduce fatigue. | Other | Face-to-Face Training Group |
| physical activity recommendationPatients will be informed about the importance of lifestyle change in disease management, walking training will be given to increase their physical activity level, and participants will be asked to follow a 45-minute walking program every day within their own means. | Other | Home-Based Control Group |
Primary outcome
Change from baseline intrahepatic lipid percentage
Time frame: Change from baseline intrahepatic lipid percentage to 16th week
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver, developed in order to facilitate, by enriching, patient recruitment for clinical trials in NASH. The PDFF method is the most objective method for lipid measurement in the liver.
Change from baseline hepatic steatosis percentage
Time frame: Change from baseline steatosis percentage to 16th week
Magnetic Resonance Elastography (MRE) is a technology that combines MRI imaging with low-frequency vibrations to create a visual map (elastogram) that shows the stiffness of body tissues. Currently, MRE is used to detect stiffening of the liver caused by fibrosis and inflammation in chronic liver disease. In chronic liver disease, before reaching the stage of cirrhosis, while detecting fibrosis in the early stages, a tissue stiffness map called elastogram can be drawn. Because the waves can be visualized and analyzed deep in the liver, MRE can evaluate much larger amounts of the total liver than a liver biopsy and has been shown to have high diagnostic accuracy in studies.
Change of liver function parameters level
Time frame: Change from baseline liver function parameters level to 16th week
Routine liver function test results including alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin, and bilirubin will be measured. All parameters will be recorded in IU/L.The ALT and AST tests measure enzymes that the liver releases in response to damage or disease. The albumin test measures how well the liver creates albumin, while the bilirubin test measures how well it disposes of bilirubin. ALP can be used to evaluate the bile duct system of the liver.
Change of lipid panel
Time frame: Change from baseline lipid panel values to 16th week
The lipid panel analysis contains total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides. All parameters will be recorded in mg/dL. Higher than normal cholesterol levels are associated with cardiovascular and metabolic diseases. Also, high total cholesterol LDL or triglyceride ratios are associated with NASH. Therefore, the lipid profile is evaluated to monitor NASH progression.
12 secondary outcomes
Evaluation of inflammatory markers
Time frame: 5 minutes, through study completion, an average of 16 weeks, change from baseline inflammatory marker status at 16 weeks.
Evaluation of aerobic capacity
Time frame: 12 minutes, through study completion, an average of 16 weeks, change from baseline aerobic capacity at 16 weeks.
Evaluation of physical activity level
Time frame: 5 minutes, through study completion, an average of 16 weeks, change from baseline physical activity level at 16 weeks.
Evaluation of muscle strength
Time frame: 10 minutes, through study completion, an average of 16 weeks, change from baseline fatique status at 16 weeks
Evaluation of fatigue
Time frame: 5 minutes, through study completion, an average of 16 weeks, change from baseline fatique status at 16 weeks
Evaluation of pain
Time frame: 5 minutes, through study completion, an average of 16 weeks, change from baseline pain status at 16 weeks
Evaluation of quality of life
Time frame: 10 minutes, through study completion, an average of 16 weeks, change from baseline quality of life at 16 weeks
Evaluation of anxiety and depression
Time frame: 7 minutes, through study completion, an average of 16 weeks, change from baseline anxiety and depression status at 16 weeks
Evaluation of dynamic balance
Time frame: 5 minutes, through study completion, an average of 16 weeks, change from baseline dynamic balance at 16 weeks
Evaluation of body mass index (BMI)
Time frame: 5 minutes, through study completion, an average of 16 weeks, change from baseline body mass index at 16 weeks
Evaluation of body fat percentage
Time frame: 5 minutes, through study completion, an average of 16 weeks, change from baseline body fat percentage at 16 weeks
Daily calorie follow-up
Time frame: 5 minutes, through study completion, an average of 16 weeks, change from baseline daily diet statusat 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance and aerobic exercise and physical activity recommendation in people with Non-Alcoholic Steatohepatitis, run by Hacettepe 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 7 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. 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?
Results are not available in the source record.
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?
Change from baseline intrahepatic lipid percentage (time frame: Change from baseline intrahepatic lipid percentage to 16th week). The study lists 4 primary outcomes in all. 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 28 Jun 2024.