Mobile health exercise program for patients with nonalcoholic steatohepatitis
Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients with Nonalcoholic Steatohepatitis
This study is testing a mobile exercise program to see if it can help people with nonalcoholic steatohepatitis (NASH) stay active and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT06195943 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility, safety, and acceptability of the Exercise and Liver FITness (EL-FIT) program, a mobile health exercise training initiative designed for patients with nonalcoholic steatohepatitis (NASH). Participants will engage in an exercise intervention facilitated through the EL-FIT app, which has previously been validated in patients with cirrhosis. The study aims to determine how well this program can be integrated into the lives of patients with NASH and assess its overall safety and acceptability. By focusing on a mobile health approach, the study seeks to enhance patient engagement and adherence to exercise regimens.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with a confirmed diagnosis of nonalcoholic steatohepatitis and access to a smartphone.
Not a fit: Patients with active cardiac symptoms, recent participation in exercise programs, or those with cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could improve liver health and overall fitness in patients with nonalcoholic steatohepatitis.
How similar studies have performed: While this approach is novel for NASH, similar mobile health interventions have shown promise in other patient populations.
Eligibility criteria
Show full inclusion / exclusion 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 * Other chronic liver disease (e.g., viral hepatitis)
Where this trial is running
Hershey, Pennsylvania
- Penn State Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan G Stine, MD — Penn State Health
- Study coordinator: Breianna Hummer-Bair, MS
- Email: bhummer@pennstatehealth.psu.edu
- Phone: 717-531-0003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.