Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis
Conditions
Keywords
fatty liver, NASH, NAFLD
Brief 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.
Interventions
BEHAVIORALModerate 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.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
•Enrollment and completion of IRB study # 00011797
Exclusion criteria
* Inability to provide informed consent * Institutionalized/prisoner * Non-English-speaking patients due to unavailability of translators for all visits/sessions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hepatic fibrosis stage using METAVIR score | 12 months | The primary endpoint of this study is change in hepatic fibrosis stage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| flow mediated dilation | 12 months | correlation between fibrosis change and improvements in FMD |
| NAFLD Activity Score (NAS) | 12 months | The diagnosis of nonalcoholic steatohepatitis (NASH) is defined by the presence and pattern of specific histological abnormalities on liver biopsy. A separate system of scoring the features of nonalcoholic fatty liver disease (NA) called the NAFLD Activity Score (NAS) was developed as a tool to measure changes in NAFLD. The grading or NAFLD activity score (NAS) encompasses steatosis, lobular inflammation and ballooning. |
| fibrosis change and gains in cardiorespiratory fitness | 12 months | correlation between fibrosis change and gains in CRF |
| health related quality of life (HRQOL) | 12 months | PROMIS is a computer adaptive test (CATs) used to assess health related quality of life. The survey contains profiles that measure multiple concepts through a fixed collection of short forms. |
| Body composition | 12 months | body composition change |
| intra-hepatic fat content | 12 months | changes in intra-hepatic fat content |
Outcome results
None listed