Exercise, Liver, NASH, NASH - Nonalcoholic Steatohepatitis
Conditions
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 cirrhosis in patients with nonalcoholic steatohepatitis.
Interventions
BEHAVIORALExercise 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.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects that complete at least 50% of the exercise sessions | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJustin G Tondt, MD
Penn State Health
Outcome results
None listed