RECRUITINGINTERVENTIONAL
Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
- Inability to walk \> 2 blocks
- Institutionalized/prisoner
- Other chronic liver disease (e.g., viral hepatitis)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
BEHAVIORAL
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.
Locations (1)
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States