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

RECRUITINGN/ASponsored by Milton S. Hershey Medical Center
Actively Recruiting
PhaseN/A
SponsorMilton S. Hershey Medical Center
Started2024-02-01
Est. completion2026-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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)

Conditions5

ExerciseLiverLiver DiseaseNASHNASH - Nonalcoholic Steatohepatitis

Locations1 site

Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Brei Hummer, MS717-531-0003bhummer@pennstatehealth.psu.edu

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