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

Penn State Health

Status: Enrolling

Conditions: NASH; Liver; NASH - Nonalcoholic Steatohepatitis; Exercise

Treatments: Behavioral: Exercise Intervention with use of El-Fit App

Study type: Interventional

Funder types: Other

Identifiers

NCT06195943

22771

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Application Useage Arm

Other group

Description:

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.

Treatment:

Behavioral: Exercise Intervention with use of El-Fit App