RECRUITING

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

Conditions

NASH - Nonalcoholic Steatohepatitis NASH Exercise Liver

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-01

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06195943

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Breianna Hummer-Bair, MS

CONTACT

717-531-0003

bhummer@pennstatehealth.psu.edu

Nataloya Smith, PhD

CONTACT

717-531-0003

nsmith9@pennstatehealth.psu.edu

Principal Investigator

Jonathan G Stine, MD

PRINCIPAL_INVESTIGATOR

Penn State Health

Study Locations (Sites)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

Jonathan G Stine, MD, PRINCIPAL_INVESTIGATOR, Penn State Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2024-02-01

Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

NASH - Nonalcoholic Steatohepatitis
NASH
Exercise
Liver