RecruitingNot ApplicableNCT06195943
Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients With Nonalcoholic Steatohepatitis
Sponsor
Milton S. Hershey Medical Center
Enrollment
20 participants
Start Date
Feb 1, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria11
- 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)
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Interventions
BEHAVIORALExercise 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(1)
View Full Details on ClinicalTrials.gov
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NCT06195943
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