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

Launched by MILTON S. HERSHEY MEDICAL CENTER · Jan 6, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new exercise program called Exercise and Liver FITness (EL-FIT) for people with Nonalcoholic Steatohepatitis (NASH), a condition that affects the liver. The goal is to see if this mobile health program is safe, easy to use, and accepted by patients. This study is currently looking for adults aged 18 and older who have been diagnosed with NASH through specific medical tests. To participate, you will need to have a smartphone and meet certain health criteria, such as not having serious heart issues or other major liver diseases.

If eligible, participants can expect to take part in a structured exercise program delivered through their mobile device, which aims to improve their fitness and overall health. The study is designed to be flexible but will also include regular check-ins to ensure safety. It's an exciting opportunity to contribute to understanding how exercise can help manage liver health, and participants will be helping to develop a program that may benefit others in the future.

Gender

ALL

Eligibility criteria

• 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)