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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195943
• Other study ID #: 22771
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Milton S. Hershey Medical Center
• Contact: Breianna Hummer-Bair, MS
• Phone: 717-531-0003
• Email: bhummer[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Exercise
• Fatty Liver
• Liver
• NASH
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

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

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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