Enrolling by invitationNo phase

Exercise Study for People with Hepatitis B and Fatty Liver Disease

Tests whether an exercise program helps adults with hepatitis B and fatty liver disease.

Key facts

Who runs it: National Taiwan University Hospital
Where: Taipei, TaiwanSee the site
Trial code: NCT05956379
Registry title: Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.
Status: Enrolling by invitation
People taking part: 100 people, planned
Started: 1 Aug 2023
Expected to end: 31 Jul 2027
Type of study: Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested: exercise
Record updated: 21 July 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-term hepatitis B and fatty liver who have not yet been treated for hepatitis B and can exercise.

Age: Over 18 years and up to 70 years.
Sex: Men and women can join.
Disease stage: Hepatitis B surface antigen (HBsAg) positive for more than 6 months, with fatty liver seen on both abdominal ultrasound and Fibroscan (CAP>215).
Earlier treatment: Must not have had hepatitis B treatment before (treatment naïve).
Biomarker or test result: HBsAg positive for more than 6 months; Fibroscan CAP>215.

Main reasons for not taking part

Liver cirrhosis or liver decompensation
Meeting the reimbursement criteria for hepatitis B treatment
Severe heart or lung disease
Serious hip or knee problems that prevent exercise
Active hepatitis C or HIV infection

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

Age >18 years of age
Either gender
HBV treatment naïve
Capable of taking exercise
HBsAg positivity for >6 months
Evidence of fatty liver in both abdominal ultrasonography and Fibroscan™(CAP>215)

Who cannot take part

Patients fulfilling reimbursement criteria for HBV treatment
Evidence of severe cardiopulmonary diseases
Clinical diagnosis of Alzheimer's Disease
Thyroid disease
Evidence of active HCV (positive for serum HCV RNA) or HIV infection (positive for anti-HCV)
Age >70 years of age
Evidence of liver cirrhosis
Evidence of serious hip or knee problems, incapable of taking exercise
Evidence of liver decompensation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 70 years old?

Where in Taiwan

National Taiwan University HospitalTaipei, TaiwanNo longer taking part

About the trial

What the trial wants to find out

In Taiwan, HBV infection is endemic in the adult population. With the westernization of eating habit and lifestyle, metabolic syndrome and related non-alcoholic fatty liver diseases (NAFLD, newly proposed as metabolic dysfunction associated fatty liver diseases, MAFLD) has become another important health issue. It is therefore common to encounter subjects with concurrent MAFLD and HBV infection in HBV endemic countries. This project will study the clinical data of patients with concurrent MAFLD and HBV, and aim to explore the impact of exercise intervention on the hepatic fatty infiltration, alteration of gut microbiota and HBV replication status in this group of patients. The research strategies will include (1) improving fatty liver and metabolic syndrome in subjects with concurrent MAFLD and HBV; and (2) exploring the changes of HBV replication and intestinal microflora in patients with concurrent HBV and MAFLD after exercise intervention.

The 2 groups in the trial

Exercise groupTreatment being tested
Physical therapists will provide personalized aerobic exercise program prescriptions in the preparatory period based on the results of exercise-related assessments, and the training intensity is based on the results of the maximum exercise test, with moderate intensity for 24 weeks, \>=3 cardio workouts per week.
Treatment: exercise
Control groupNo study treatment, for comparison
No change in exercise habits and maintaining baseline physical activity.