Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis

NCT06195943 | Completed

• 1 other identifier: 22771
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

NASH; Exercise; Liver; NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Number of subjects that complete at least 50% of the exercise sessions

  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.

  8 weeks

Study Arms (1)

Application Useage Arm

OTHER

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.

Behavioral: Exercise Intervention with use of El-Fit App

Interventions

Exercise Intervention with use of El-Fit App BEHAVIORAL

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.

Application Useage Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Motor Activity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Behavior

Study Officials

• Justin G Tondt, MD

  Penn State Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family and Community Medicine and Public Health Sciences

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 8, 2024
• Study Start: February 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)