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

Not Applicable

Recruiting

• Conditions: NASH - Nonalcoholic Steatohepatitis; Exercise; Liver; NASH
• Interventions: Behavioral: Exercise Intervention with use of El-Fit App

• Registration Number: NCT06195943
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-08
• Study Start: 2024-02-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Application Useage Arm	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.

Primary Outcome Measures

Name	Time	Method
Number of subjects that complete at least 50% of the exercise sessions	8 weeks	The primary study endpoint is feasibility of the use of the application, which is defined as \>50% of subjects adhering to the exercise prescribed, defined as completing \>50% of the sessions.

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States