Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Ghent
About this trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD.
In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with MASLD by ultrasound, CAP and/or biopsy
Age between 18 and 75 years old
No significant liver fibrosis (Fibroscan < 7.5 kPa; if it is between >7.5 and <10, there must be absence of liver fibrosis in the biopsy)
Disqualifiers
Presence of other liver diseases that may contribute to the clinical presentation in the patient
Severe cardiovascular, orthopedic, physical or other illnesses that make it impossible to participate in the study's exercise rehabilitation program or where safety cannot be guaranteed
Pregnancy
Pharmacological treatment that directly affects MASLD (e.g. GLP-1 analogues)
Trial design
Design model
Parallel
Treatments tested in this trial
Combined aerobic + strength training
Other interventionParticipants will follow a combination of endurance and strength training for 14 weeks. There will be three sessions every week: two at Ghent university department of rehabilitation and one at home. Each session will last approximately one hour.
Combined strength + HIIT training
Other intervention6 weeks of endurance training and strength training, 8 weeks of strength training and HIIT. Participants will follow the same combination of endurance and strength training for the first six weeks, to build up to a baseline level of physical fitness. They will then switch to eight weeks of a combination of strength training and High Intensity Interval Training (HIIT). There will be three sessions every week: two at Ghent university department of rehabilitation and one at home. Each session will last approximately one hour.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Combined strength + aerobic trainingActive comparator 1 intervention
Group B: Combined strength + HIITExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Liver steatosis by CAP
Liver stiffness measurement will be performed using vibration-controlled transient elastography, more specifically the Fibroscan. This method measures the fat accumulation in the liver (dB/m) and the level of scar tissue (kPa), represented as the CAP or steatosis score and the fibrosis score respectively.
Time frame
before training and after training (14 weeks)2
Liver steatosis on ultrasound
Ultrasound can demonstrate hepatic fatty tissue, estimating severity based on liver-kidney contrast, resolution loss thv the intrahepatic blood vessels, and visibility of the diaphragm. On this basis, a score 0-3 can be assigned.
Time frame
before training and after training (14 weeks)Secondary outcomes
1
Insulin sensitivity
Insulin sensitivity will be assessed by calculation of the HOMA-IR index (fasting glucose x insulin)
Time frame
before training and after training (14 weeks)2
Liver transaminases
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes located primarily in liver cells. An elevation of these enzymes in the bloodstream may indicate liver damage or inflammation.
Time frame
before training and after training (14 weeks)3
Maximal exercise test
A ramp protocol will be performed starting at 25 watts, adding 25 watts per minute each time. This test will be administered using ergospirometry to derive measures for aerobic physical condition.
Time frame
before training and after training (14 weeks)4
Strength
Strength will be measured by 1RM determination of the muscle groups that will be trained (leg press, adductors, vertical traction, chest press, abdominal and back muscles). This measurement will be performed at baseline, after 10 weeks and at the end of the study
Time frame
before training and after training (14 weeks)Sponsors and contacts
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University Ghent
Lead sponsor
University Hospital, Ghent
Collaborator
Source ClinicalTrials.gov