Exercise Program for Fatty Liver Disease

Overseen By Nataloya Smith, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Cirrhosis, Cancer, Cardiac symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an app-based exercise program can assist individuals with nonalcoholic steatohepatitis (NASH), a liver disease often associated with fat buildup. Participants will use a Fitbit and the El-Fit app to track and engage in daily exercise at their own pace. The trial aims to determine if this exercise program is safe, feasible, and well-received. It suits adults diagnosed with NASH who own a smartphone and are not currently in an exercise program. As an unphased trial, it provides a unique opportunity to contribute to innovative research and potentially enhance health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that active weight-loss supplement use is not allowed, except for GLP-1 receptor agonists.

What prior data suggests that this exercise program is safe for patients with nonalcoholic steatohepatitis?

Research has shown that exercise can improve fatty liver disease and may even help repair liver damage. The EL-FIT app motivates people to exercise and has been used by those with serious liver issues.

Previous studies found the EL-FIT app safe, with no major reports of harm. This app enables people to exercise at home, offering convenience and safety for many.

In general, exercise is well-tolerated, and most people can safely increase their activity levels. However, consulting a doctor before starting any new exercise routine is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing fatty liver disease through an exercise program integrated with the El-Fit app. Unlike traditional treatments that often rely on medication or dietary changes, this method leverages technology to encourage physical activity, making it more accessible and engaging for participants. The El-Fit app, used in conjunction with a daily Fitbit, allows individuals to track their exercise in a flexible manner, offering a personalized experience that could lead to improved adherence and outcomes. This innovative use of technology could offer a more sustainable and enjoyable way to manage fatty liver disease.

What evidence suggests that this exercise program is effective for fatty liver disease?

Research has shown that the EL-FIT app can help people with liver conditions become more active. Initially tested with patients who have severe liver disease, the app showed promising results. Exercise is known to improve liver health by reducing fat and swelling in the liver, which is crucial for conditions like nonalcoholic steatohepatitis, a type of fatty liver disease. In this trial, participants in the Application Usage Arm will use the EL-FIT app to engage in daily exercise as much or as little as they choose. While the EL-FIT app has proven effective for patients with cirrhosis, the goal is to determine if it can work just as well for those with fatty liver disease. Early findings suggest the app might make regular exercise easier and more manageable for patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Justin G Tondt, MD

Principal Investigator

Penn State Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with nonalcoholic steatohepatitis (NASH), confirmed by a liver biopsy or certain tests within the last 6 months. Participants must own a smartphone to use the El-Fit App, which is part of the exercise program being tested.

Inclusion Criteria

I have been diagnosed with NASH.

I own a smartphone.

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the EL-FIT app and wear a Fitbit daily to engage in exercise as much or as little as they want

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention with El-Fit App

Trial Overview The study is testing 'EL-FIT', a mobile health (mHealth) exercise training program designed for patients with NASH. The focus is on seeing if it's practical, safe, and acceptable when delivered through an app called El-Fit.

How Is the Trial Designed?

Group I: Application Useage Arm Experimental Treatment 1 Intervention

Along with wearing their Fitbit daily, subjects will be asked to use El-Fit app to participant in daily exercise as much or a little as they want over the course of the study.

Exercise Intervention with El-Fit App is already approved in United States, European Union, China for the following indications:

Approved in United States as Exercise Intervention for:

• Nonalcoholic Steatohepatitis
• Nonalcoholic Fatty Liver Disease

Approved in European Union as Physical Activity for:

• Nonalcoholic Fatty Liver Disease
• Obesity-related conditions

Approved in China as Exercise Therapy for:

• Nonalcoholic Fatty Liver Disease
• Central Obesity

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

Regular physical activity (PA) is essential for managing nonalcoholic fatty liver disease (NAFLD), leading to benefits such as reduced liver fat and improved overall health, even without significant weight loss.

Patients with NAFLD should aim for at least 150 minutes of moderate or 75 minutes of vigorous PA weekly, with a combination of aerobic and resistance training being the most effective approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Nonalcoholic Fatty Liver Disease: A Roundtable Statement from the American College of Sports Medicine. Stine, JG., Long, MT., Corey, KE., et al.[2023]

A 20-week telehealth-based exercise program for three patients with nonalcoholic steatohepatitis (NASH) was found to be feasible and safe, with all participants completing over 80% of their sessions and no adverse events reported.

The program led to significant health improvements, including a 5.1% reduction in body weight, a 35.1% decrease in liver fat as measured by MRI, and enhanced fitness levels, indicating that telehealth can effectively support exercise in patients with NASH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of a Directly Supervised Telehealth-Based Exercise Training Program in Patients With Nonalcoholic Steatohepatitis: Feasibility Study. Motz, V., Faust, A., Dahmus, J., et al.[2021]

The study provides a comprehensive exercise prescription for patients with fatty liver, emphasizing basic exercises like brisk walking and jogging, as well as sports such as swimming and cycling to enhance physical strength and endurance.

Key components of the exercise intervention include guidelines on intensity, duration, frequency, and safety precautions, ensuring a tailored approach to rehabilitation for fatty liver patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Prescription Intervention Rehabilitation Suggestions for Fatty Liver Patients. Wan, T., Hong, KD., Lu, SY.[2022]

Exercise has been shown to reduce liver fat in individuals with nonalcoholic fatty liver disease (NAFLD), potentially by decreasing the liver's production of fat (hepatic lipogenesis).

Incorporating exercise into the management of fatty liver disorders is crucial, but simply informing patients about its benefits is not enough; effective strategies must focus on behavior change and personalized fitness goals to achieve positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and the liver: implications for therapy in fatty liver disorders. Johnson, NA., Keating, SE., George, J.[2022]

Intense psychological support for physical activity (PA) in patients with nonalcoholic fatty liver disease (NAFLD) led to significant improvements in physical fitness, with a greater increase in the 6-minute walk test and VO2max compared to cognitive-behavioral treatment (CBT).

While both PA and CBT groups showed similar improvements in liver fat and enzyme levels, the PA group had a higher percentage of participants engaging in moderate-to-heavy physical activity, suggesting that exercise promotion can be effective, especially for motivated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity support or weight loss counseling for nonalcoholic fatty liver disease? Montesi, L., Caselli, C., Centis, E., et al.[2021]

A lifestyle intervention significantly increased physical activity among participants with nonalcoholic fatty liver disease, with those in the intervention groups being 9 times more likely to increase their activity by an hour or more per week compared to the control group.

Maintaining or increasing physical activity to at least 150 minutes per week led to the greatest improvements in liver enzymes and metabolic health, independent of weight loss, highlighting the importance of physical activity in managing fatty liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Independent effects of physical activity in patients with nonalcoholic fatty liver disease. St George, A., Bauman, A., Johnston, A., et al.[2021]

An 8-week Web-based exercise intervention significantly improved cardiorespiratory fitness (measured as VO2peak) by 2.4 mL/kg/min (8.8%) in patients with nonalcoholic fatty liver disease (NAFLD), with no adverse events reported during the study involving 44 participants.

Patients with lower body fat and VO2peak at baseline experienced the most benefit from the intervention, suggesting that a combination of nutritional strategies to reduce body fat may enhance the effectiveness of exercise programs for NAFLD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Exercise as an Effective Complementary Treatment for Patients With Nonalcoholic Fatty Liver Disease: Intervention Study. Pfirrmann, D., Huber, Y., Schattenberg, JM., et al.[2020]

Exercise significantly improves clinical parameters such as BMI, ALT, and lipid metabolism in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM), based on a meta-analysis of 6 studies involving 238 subjects.

High-intensity interval training was particularly effective in reducing BMI, ALT, total cholesterol (TC), LDL cholesterol (LDL-C), HbA1c, and HOMA-IR, while moderate-intensity continuous training also showed benefits for ALT, triglycerides (TG), and HbA1c, indicating that the type of exercise influences the outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise intervention on clinical parameters in patients with non-alcoholic fatty liver disease and type 2 diabetes mellitus: a meta-analysis of randomized controlled trials. Zeng, Y., Zhang, X., Luo, W., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33232547/

Introducing EL-FIT (Exercise and Liver FITness) - PubMed - NIH We created a smartphone application (app), EL-FIT (Exercise and Liver FITness), to facilitate exercise training in end-stage liver disease (ESLD).

2. withpower.com withpower.com/trial/phase-non-alcoholic-fatty-liver-disease-2024-7c09c

Exercise Program for Fatty Liver Disease Approved in United States as Exercise Intervention for: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease.. Approved in ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04604860

Use of EL-FIT App to Promote Physical Activity There are three types of expanded access: Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical ...

4. el-fit.pitt.edu el-fit.pitt.edu/

Home | EL-Fit | University of Pittsburgh EL-FIT: The Physical Fitness App for Advanced Liver Disease. Center for Liver Disease and Starzl Transplantation Institute. Kaufmann Medical Building, Suite ...

5. researchgate.net researchgate.net/publication/347170794_Introducing_EL-FIT_Exercise_and_Liver_FITness_A_Smartphone_App_to_Prehabilitate_and_Monitor_Liver_Transplant_Candidates

A Smartphone App to Prehabilitate and Monitor Liver ... ... physical activity and nonalcoholic fatty liver disease. Article. Mar 2023. Jonathan Stine · Michelle T Long ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5954622/

The Effects of Physical Exercise on Fatty Liver Disease - PMC We can infer from these results that exercise has a beneficial effect on the reversal of histologically proven fatty liver disease.