RECRUITINGINTERVENTIONAL

NASH AMPK Exercise Dosing (AMPED) Trial

About This Trial

There is no known cure or regulatory agency approved drug therapy for nonalcoholic fatty liver disease (NAFLD), the leading cause of liver disease worldwide, and its progressive type, NASH. This places increased importance on using exercise to treat NAFLD. While physical activity is recommended for all with NAFLD, how to best prescribe exercise as a specific treatment remains unknown, including what dose of exercise is most effective.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18-69 years - Sedentary \[\<90 min/wk of exercise identified by the Get Active Questionnaire (GAQ) - BMI \>25kg/m2 - Liver biopsy within six months prior to enrollment showing: - NASH defined by NASH Clinical Research Network (CRN) histology scoring system (NAS) \>4 and MRI-PDFF \>5% and; - Liver fibrosis stage 1-3 Who Should NOT Join This Trial: - Active cardiac symptoms - Body mass index (BMI) \>45kg/m2 - Cancer that is active - Inability to walk \>2 blocks - Institutionalized/prisoner - Other liver disease - Pregnancy - Secondary hepatic steatosis - Severe comorbidities - AUDIT-C questionnaire identified significant alcohol use - Substance abuse/active smoking - Uncontrolled diabetes (changes in drug dosing over previous three months or A1c \>9%) - GAQ response indicates exercise may be unsafe. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age 18-69 years * Sedentary \[\<90 min/wk of exercise identified by the Get Active Questionnaire (GAQ) * BMI \>25kg/m2 * Liver biopsy within six months prior to enrollment showing: * NASH defined by NASH Clinical Research Network (CRN) histology scoring system (NAS) \>4 and MRI-PDFF \>5% and; * Liver fibrosis stage 1-3 Exclusion Criteria: * Active cardiac symptoms * Body mass index (BMI) \>45kg/m2 * Cancer that is active * Inability to walk \>2 blocks * Institutionalized/prisoner * Other liver disease * Pregnancy * Secondary hepatic steatosis * Severe comorbidities * AUDIT-C questionnaire identified significant alcohol use * Substance abuse/active smoking * Uncontrolled diabetes (changes in drug dosing over previous three months or A1c \>9%) * GAQ response indicates exercise may be unsafe.

Treatments Being Tested

BEHAVIORAL

Exercise

Aerobic exercise can be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking (30-40% target HR for 5-min) and dynamic exercises (knee-to-chest, 10-yd lateral shuffle, bent over twist, calf sweeps, leg swings). A 5-min walking cool down will end the session (30-40% target HR).

Locations (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States