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High-Intensity Interval Training for Non-alcoholic Fatty Liver Disease (AMPED Trial)

N/A

Recruiting

Led By Jonathan G Stine

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-69 years

Liver fibrosis stage 1-3

Must not have

Secondary hepatic steatosis

Inability to walk >2 blocks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial found that a single session of high-intensity interval training (HIIT) improved liver fat and insulin sensitivity in those with NAFLD.

Who is the study for?

The AMPED trial is for adults aged 18-69 with a BMI over 30 who are mostly inactive and have been diagnosed with NASH, a type of liver disease. They must have had a liver biopsy within the last six months showing specific levels of liver damage. People can't join if they're very overweight (BMI >45), have heart problems, other liver diseases, severe health issues, drink too much alcohol or use drugs.

What is being tested?

This study looks at how different amounts of exercise can help treat non-alcoholic fatty liver disease (NAFLD) since there's no approved drug treatment yet. It aims to find out what 'dose' of exercise works best for patients with NAFLD.

What are the potential side effects?

Since the intervention in this trial is exercise, side effects might include typical reactions to increased physical activity such as muscle soreness, fatigue or injury. The exact side effects will depend on each person's condition and fitness level.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 69 years old.

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My liver has mild to moderate scarring.

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My liver condition is confirmed by specific tests to be severe.

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My liver biopsy shows I have NASH with a NAS score over 4, MRI-PDFF over 5%, and fibrosis stage 1-3.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have fatty liver disease not caused by alcohol.

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I cannot walk more than 2 blocks without stopping.

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I am currently experiencing heart problems.

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My cancer is currently active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in liver fat

Secondary study objectives

Adiponectin

Body mass index

Change in stiffness of the liver

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Exercise Arm 2Experimental Treatment1 Intervention

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.

Group II: Exercise Arm 1Experimental Treatment1 Intervention

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.

Group III: Standard of CareActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 8Eligibility criteria met