RecruitingNot ApplicableNCT06195943

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

Sponsor

Milton S. Hershey Medical Center

Enrollment

20 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Exercise NASH NASH - Nonalcoholic Steatohepatitis Liver

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria11

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)

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Interventions

BEHAVIORALExercise 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.