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

NCT03864835 | Withdrawn

• 1 other identifier: STUDY00012210
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

fatty liver; NASH; NAFLD

Outcome Measures

Primary Outcomes (1)

• hepatic fibrosis stage using METAVIR score

  The primary endpoint of this study is change in hepatic fibrosis stage.

  12 months

Secondary Outcomes (6)

• fibrosis change and gains in cardiorespiratory fitness

  12 months

• flow mediated dilation

  12 months

• NAFLD Activity Score (NAS)

  12 months

• intra-hepatic fat content

  12 months

• health related quality of life (HRQOL)

  12 months

Study Arms (1)

Moderate intensity aerobic exercise

EXPERIMENTAL

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.

Behavioral: Moderate intensity aerobic exercise

Interventions

Moderate intensity aerobic exercise 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.

Moderate intensity aerobic exercise

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment and completion of IRB study # 00011797

You may not qualify if:

• Inability to provide informed consent
• Institutionalized/prisoner
• Non-English-speaking patients due to unavailability of translators for all visits/sessions

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Jonathan G Stine, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center Assistant Professor of Medicine and Public Health Sciences

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 6, 2019
• Study Start: November 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share