Exercise Program for Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

Overseen by Jonathan G Stine, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Cirrhosis, Cancer, Cardiac symptoms, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will be a pilot study to evaluate the feasibility, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously validated in patients with cirrhosis in patients with nonalcoholic steatohepatitis.

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 data supports the effectiveness of the treatment Exercise Intervention with El-Fit App for Fatty Liver Disease?

Research shows that increasing physical activity can improve liver health in people with fatty liver disease. Studies have found that exercise programs, including those delivered through web-based or telehealth platforms, can enhance physical fitness and improve liver enzyme levels, which are important for liver function. ^{1 2 3 4 5}

Is exercise generally safe for people with fatty liver disease?

Exercise programs, including those delivered via telehealth, are generally considered safe for people with fatty liver disease. These programs often include activities like walking, jogging, swimming, and cycling, and are designed to improve overall fitness and liver health. ^{1 2 3 5 6}

How is the Exercise Intervention with El-Fit App treatment unique for fatty liver disease?

The Exercise Intervention with El-Fit App is unique because it uses a telehealth-based approach to deliver exercise programs, making it more accessible and potentially more cost-effective than traditional face-to-face exercise programs. This method aims to increase physical activity among patients with fatty liver disease, who are often physically inactive, by providing personalized exercise guidance and support remotely. ^{1 2 3 7 8}

Research Team

Jonathan G Stine, MD

Principal Investigator

Penn State Health

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Exercise Intervention with El-Fit App (Behavioral Intervention)

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.

Participant Groups

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 China for the following indications:

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+

Dr. Robert Harbaugh

Milton S. Hershey Medical Center

Chief Medical Officer since 2024

MD from Penn State College of Medicine

Don McKenna

Milton S. Hershey Medical Center

Chief Executive Officer since 2024

Master’s in Public Administration and Bachelor of Science in Business Administration and Marketing from Long Island University

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exercise Prescription Intervention Rehabilitation Suggestions for Fatty Liver Patients. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Utilization of a Directly Supervised Telehealth-Based Exercise Training Program in Patients With Nonalcoholic Steatohepatitis: Feasibility Study. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Exercise as an Effective Complementary Treatment for Patients With Nonalcoholic Fatty Liver Disease: Intervention Study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Physical activity support or weight loss counseling for nonalcoholic fatty liver disease? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Independent effects of physical activity in patients with nonalcoholic fatty liver disease. [2021]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Nonalcoholic Fatty Liver Disease: A Roundtable Statement from the American College of Sports Medicine. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise and the liver: implications for therapy in fatty liver disorders. [2022]