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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

AMPED Trial 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.Check my eligibility
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.See study design
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.

AMPED Trial 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 BMI is over 30.
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My liver condition is confirmed by specific tests to be severe.
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I am between 18 and 69 years old.
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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.

AMPED Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in liver fat
Secondary outcome measures
Adiponectin
Body mass index
Change in stiffness of the liver
+13 more

AMPED 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
~760

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
491 Previous Clinical Trials
2,798,760 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
84 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Jonathan G StinePrincipal InvestigatorMilton S. Hershey Medical Center

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04987879 — N/A
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04987879 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987879 — N/A
Non-alcoholic Fatty Liver Disease Research Study Groups: Standard of Care, Exercise Arm 2, Exercise Arm 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still enrolling participants?

"The trial, which was first listed on August 30th 2022 and recently modified on November 14th 2022, is calling for participants according to data hosted by clinicaltrials.gov."

Answered by AI

Who would be an appropriate candidate for participation in this clinical experiment?

"The eligibility criteria for this research endeavour stipulates that patients should have Non-Alcoholic Fatty Liver Disease and be between 18 to 69 years of age. Approximately 45 individuals will be selected as participants in the study."

Answered by AI

Is this research project accepting participants over the age of 40?

"This clinical trial is open to adult patients, aged 18 - 69."

Answered by AI

What is the cumulative enrollment of this experiment?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently in recruitment mode, as it was initially posted on August 30th 2022 and last amended on November 14th 2022. There are 45 participants needed from 1 medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Penn State Hershey Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~22 spots leftby Oct 2025