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OpenTrials
Completed

NCT Number: NCT06195943

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise Intervention with use of El-Fit App

Behavioral

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 outcomes

  1. Number of subjects that complete at least 50% of the exercise sessions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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