NASH Fitness Intervention in Thrombosis Trial (NASHFit)

NCT03518294 | Completed Results DMC

• 1 other identifier: 8507
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States. The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival. The current standard of care for NAFLD is lifestyle changes through diet and exercise. The human genome and regulation of gene expression is influenced by physical activity. NAFLD is a prothrombotic state with derangements in all three phases of hemostasis leading to clinically important clotting events. Exercise can improve coagulation in healthy persons. In this proposal, we seek to begin a line of work to answer the question "Can lifestyle changes effectively mitigate the increased risk of clotting in patients with NAFLD?" focusing initially on the at-risk population genetically susceptible to advanced disease.

Conditions

Liver Diseases; Blood Disorder; Digestive System Disease

Keywords

NAFLD; NASH

Outcome Measures

Primary Outcomes (1)

• PAI-1 Level

  Change in fibrinolysis as indicated by PAI-1 level was calculated by taking the difference of measurements at baseline and 5 months.

  5 months

Secondary Outcomes (11)

• Change in Von Williebrand Factor (vWF)

  5 months

• Change in Protein S

  5 months

• Change in Factor VIII

  5 months

• Change in Fibrinogen

  5 months

• Change in Antithrombin

  5 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Subjects in the control condition will be instructed to continue their medical care at the discretion of their treating medical professional. They will be informed to maintain their current physical activity level. Weekly phone calls will be performed by study personnel to ensure adherence to the protocol (no changes in activity). Subjects will report to Penn State on a monthly basis for anthropometric assessment to confirm their self-reports and study investigators will perform and interim history and physical examination at that time.

Aerobic Exercise

EXPERIMENTAL

Subjects in the aerobic exercise group will be supervised to exercise 30 minutes, 5 times per week at a moderate intensity. Formal exercise instruction and supervision will be provided by ACSM certified fitness professionals at the Penn State University Fitness Center. Aerobic exercise can be completed on either the treadmill, exercise bike, rowing machine or the elliptical machine.

Behavioral: Aerobic Exercise

Interventions

Aerobic Exercise BEHAVIORAL

Subjects in the aerobic exercise group will be supervised to exercise 30 minutes, 5 times per week at a moderate intensity. Formal exercise instruction and supervision will be provided by ACSM certified fitness professionals at the Penn State University Fitness Center. Aerobic exercise can be completed on either the treadmill, exercise bike, rowing machine or the elliptical machine.

Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lack of secondary causes of hepatic fat accumulation:
• Significant alcohol consumption (\<21 drinks/week for men and \<14 drinks/week for women) Chronic hepatitis C Wilson disease Lipodystrophy Parenteral nutrition Long-term use of steatogenic medications (mipomersen, lomitapide, amiodarone, methotrexate, tamoxifen, corticosteroids) Monogenic hereditary disorders

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

• Channapragada T, Batra S, Hummer BL, Chinchilli VM, Huang D, Loomba R, Schreibman IR, Stine JG. Aerobic Exercise Training Leads to MASH Resolution as Defined by the MASH Resolution Index. Dig Dis Sci. 2025 Sep 3. doi: 10.1007/s10620-025-09361-9. Online ahead of print.

  PMID: 40900364 DERIVED

• Motz V, Faust A, Dahmus J, Stern B, Soriano C, Stine JG. Utilization of a Directly Supervised Telehealth-Based Exercise Training Program in Patients With Nonalcoholic Steatohepatitis: Feasibility Study. JMIR Form Res. 2021 Aug 17;5(8):e30239. doi: 10.2196/30239.

  PMID: 34402795 DERIVED

MeSH Terms

Conditions

Liver Diseases; Hematologic Diseases; Digestive System Diseases; Non-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Fatty Liver

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Possible limitations include the sample size, lack of allocation concealment, study population largely of early-stage NASH that was also predominantly non-Hispanic white, lack of histologic endpoint, lack of long-term clinical outcomes and inability to show global changes in hemostasis with TEG.

Results Point of Contact

• Title: Dr. Jonathan Stine
• Organization: The Penn State College of Medicine

jstine@pennstatehealth.psu.edu

7175311017

Study Officials

• Jonathan Stine, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Medicine

Model Details: Standard of care Aerobic exercise

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 8, 2018
• Study Start: June 1, 2018
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)