Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis
Overview
- Phase
- N/A
- Intervention
- Exercise Intervention with use of El-Fit App
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Number of subjects that complete at least 50% of the exercise sessions
- Status
- Completed
- Last Updated
- 24 days ago
Overview
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.
Investigators
Justin Tondt
Assistant Professor of Family and Community Medicine and Public Health Sciences
Milton S. Hershey Medical Center
Eligibility Criteria
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
Arms & Interventions
Application Useage Arm
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.
Intervention: Exercise Intervention with use of El-Fit App
Outcomes
Primary Outcomes
Number of subjects that complete at least 50% of the exercise sessions
Time Frame: 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.