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RECRUITINGINTERVENTIONAL

Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults age \>18 years - Evidence of NASH indicated by at least one of the following - Liver biopsy with evidence of steatohepatitis (NAS \>=4) within 6 months of the screening interval or; - Historical Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following non-invasive tests within 6 months of the screening interval: i. FIB-4 \>= 1.3 or; ii. NFS \>= -1.44 or; iii. ELF \>= 7.7 or; iv. VCTE kPa \>=8 or; v. ARFI \>=1.3 or; vi. FAST \>= 0.35 or; vii. MRE kPa \>=2.55 or; viii. MAST \> 0.165 or; - Possession of a smartphone Who Should NOT Join This Trial: - Active cardiac symptoms precluding participation in vigorous exercise - Active or recent participation in exercise training program within the last 90 days - Active or recent weight-loss supplement use within the last 90 days (does not include GLP-1 receptor agonist use) - Active illicit substance use - Cancer that is active - Cirrhosis - Exercise identified to be unsafe by study PI or EL-FIT mHealth program - Inability to provide willing to sign a consent form - Inability to walk \> 2 blocks - Institutionalized/prisoner - Other chronic liver disease (e.g., viral hepatitis) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Adults age \>18 years * Evidence of NASH indicated by at least one of the following * Liver biopsy with evidence of steatohepatitis (NAS \>=4) within 6 months of the screening interval or; * Historical Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following non-invasive tests within 6 months of the screening interval: i. FIB-4 \>= 1.3 or; ii. NFS \>= -1.44 or; iii. ELF \>= 7.7 or; iv. VCTE kPa \>=8 or; v. ARFI \>=1.3 or; vi. FAST \>= 0.35 or; vii. MRE kPa \>=2.55 or; viii. MAST \> 0.165 or; * Possession of a smartphone Exclusion Criteria: * Active cardiac symptoms precluding participation in vigorous exercise * Active or recent participation in exercise training program within the last 90 days * Active or recent weight-loss supplement use within the last 90 days (does not include GLP-1 receptor agonist use) * Active illicit substance use * Cancer that is active * Cirrhosis * Exercise identified to be unsafe by study PI or EL-FIT mHealth program * Inability to provide informed consent * Inability to walk \> 2 blocks * Institutionalized/prisoner * Other chronic liver disease (e.g., viral hepatitis)

Treatments Being Tested

BEHAVIORAL

Exercise Intervention with use of El-Fit App

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.

Locations (1)

Penn State Hershey Medical Center
Hershey, Pennsylvania, United States