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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
View on ClinicalTrials.gov →
NCT06195943
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
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Actively Recruiting
PhaseN/A
SponsorMilton S. Hershey Medical Center
Started2024-02-01
Est. completion2026-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06195943