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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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NASH - Nonalcoholic Steatohepatitis NASH Exercise Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Exercise Intervention with use of El-Fit App

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No