Status:
RECRUITING
Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
NASH - Nonalcoholic Steatohepatitis
NASH
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06195943
Start Date
February 1 2024
End Date
March 1 2026
Last Update
July 29 2025
Active Locations (1)
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1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033