NASH AMPK Exercise Dosing (AMPED) Trial

NCT04987879 | Recruiting

• 2 other identifiers: STUDY00018280K23DK131290
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• Change in liver fat

  Degree of liver fat change as measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) across different doses of exercise in patients with NASH.

  16 weeks

Secondary Outcomes (16)

• Hip/waist circumference

  16 weeks

• Body mass index

  16 weeks

• change in body composition

  16 weeks

• Insulin

  16 weeks

• Hemoglobin A1c

  16 weeks

Study Arms (3)

Exercise Arm 1

EXPERIMENTAL

Aerobic exercise will 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 and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 750 MET-min/wk for 3-5 days per week, 22-45 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually.

Behavioral: Exercise

Exercise Arm 2

EXPERIMENTAL

Aerobic exercise will 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 and dynamic exercises. A 5-min walking cool down will end the session. The training dose for this arm is 1,000 MET-min/wk for 3-5 days per week, 30-60 minutes per session at a moderate to vigorous intensity. The exercise can be completed in person or virtually.

Behavioral: Exercise

Standard of Care

NO INTERVENTION

This group will receive best NASH clinical practices counseling at baseline and end-of-trial in accordance with NAFLD clinical practice guidelines and be reinforced by handouts from the American Liver Foundation.

Interventions

Exercise BEHAVIORAL

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).

Also known as: Physical activity

Exercise Arm 1; Exercise Arm 2

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christopher Sciamanna, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Breianna L Hummer, MS

CONTACT

7175310003; bhummer@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine and Public Health Sciences

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 3, 2021
• Study Start: August 30, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)