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

NCT ID: NCT03864835

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-12-31

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.

Conditions

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

Keywords

fatty liver; NASH; NAFLD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate intensity aerobic exercise

All subjects will undergo DXA and CRF measurement (relative VO2max) under the supervision of an American College of Sports Medicine (ACSM)-certified fitness professional and study physician at the Penn State PM\&R Research Laboratories. Subjects selected for the interventional pilot trial will receive a FitBit Charge2 HR and be instructed on how to use a FitBit Hear Rate monitor, Fitbit application, Fitbit website, and Fitabase (secure data management platform utilized by \>400 clinical trials). Participants will record their daily food and beverage intake through the Fitbit app. Individualized feedback will be provided by a registered dietician (RD). 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.

Group Type: EXPERIMENTAL

Moderate intensity aerobic exercise

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Stine

Center Assistant Professor of Medicine and Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan G Stine, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Other Identifiers

STUDY00012210

Identifier Type: -

Identifier Source: org_study_id