N/A
N=28
NASH Fitness Intervention in Thrombosis Trial (NASHFit)
Liver Diseases · Blood Disorder · Digestive System Disease
Bottom Line
View on ClinicalTrials.gov: NCT03518294 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Feb 2023
Primary outcome: Primary: PAI-1 Level — 151.4; 176.2 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerobic Exercise (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PAI-1 Level |
151.4; 176.2 | — |
| SECONDARY Change in Von Williebrand Factor (vWF) |
140.1; 128.4 | — |
| SECONDARY Change in Protein S |
106.3; 101.5 | — |
| SECONDARY Change in Factor VIII |
210.0; 188.6 | — |
| SECONDARY Change in Fibrinogen |
352.4; 377.2 | — |
| SECONDARY Change in Antithrombin |
95.6; 102.2 | — |
| SECONDARY Change in Protein C |
169.0; 152.6 | — |
| SECONDARY Change in Adiponectin |
3482.3; 1065.1 | — |
| SECONDARY Patatin Like Phospholipase-3 (PNPLA3) rs738409 Polymorphism |
3; 8; 5; 5; 2; 5 | — |
| SECONDARY Change in PAI-1 Stratified by Fibrosis Stage |
176.7; 241.4; 131.7; 122.7; 196.1; 127.8 | — |
| SECONDARY Change in % Hepatic Fat |
22.5; 20.4 | — |
| SECONDARY Health Related Quality of Life (HRQOL) Change |
-2.5; 1.5; 4.3; -3.4; -0.7; 5.0 | — |
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.
Eligibility Criteria
Inclusion Criteria Adults age >=18 or 90 minutes/week of at least moderate intensity exercise over the previous three months Pregnancy BMI 40 kg/m2(16) Uncontrolled diabetes (changes in medication dosing over the previous three months or hemoglobin A1c >9%)(12) Active cardiac symptoms Severe medical comorbidities/psychiatric illness Decompensated cirrhosis (history of esophageal varices, ascites or hepatic encephalopathy) Abdominal hernia Cancer with life expectancy 1:160) Active weight-loss program participation or weight-loss supplement use Active substance abuse/smoking Inability to provide informed consent Institutionalized/prisoner Inability to walk > 2 blocks or ¼ mile. Physical Activity Readiness Questionnaire (PAR-Q) score >=1 at the discretion of the study PI
Data sourced from ClinicalTrials.gov (NCT03518294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.