NCT03864835

NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to find out if aerobic exercise is beneficial in reversing scarring. Physical activity has been shown to increase fitness in healthy individuals as well as in those with NASH. This research will allow for better understanding the effects of physical activity on fitness and endothelial function in patients with NASH with the goal of reversing scarring. Approximately 12 people will take part in this research study at Penn State (PSU) Milton S. Hershey Medical Center (HMC), Penn State Physical Medicine \& Research (PM\&R) Laboratories housed at the Hershey Center for Applied Research (HCAR) and the Penn State University Fitness Center (UFC).

Detailed description

Preliminary studies show universally low cardiorespiratory fitness (CRF) in Nonalcoholic steatohepatitis (NASH) patients was dependent on body composition. The proposed work is based on the hypothesis that gains in cardiorespiratory fitness and improved endothelial function achieved through exercise can arrest or reverse progression of hepatic fibrosis, lessen cardiovascular disease risk (CVD), and improve all-cause mortality in patients with NASH. The aims of this research proposal are designed to characterize and better understand the effects of physical activity (PA) on CRF and endothelial function in patients with NASH. The goal is to arrest progression of fibrosis and reduce CVD risk. This proposal includes a cross-sectional study and a small pilot clinical trial in a high-risk subgroup of NASH most likely to benefit from PA.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Non Alcoholic Steatohepatitis
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
BEHAVIORAL	Moderate intensity aerobic exercise	Subjects that meet requirements for the exercise arm (12 total) will be required to exercise 30 minutes, five days per week at a moderate intensity (HR target corresponding to 45-55% of their relative VO2max). Each session will be supervised in-person at the Penn State University Fitness Center with an ACSM certified exercise physiologist. This is feasible as Zhang et al.(87) found 66 out of 70 subjects (95%) completed the twelve-month supervised in-person moderate-intensity exercise protocol five-days a week.

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-03-06
• Last updated: 2019-11-29