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Abstract Details
NASHFit: A randomized controlled trial of an exercise training program to reduce clotting risk in patients with NASH
Hepatology. 2021 Dec 10. doi: 10.1002/hep.32274. Online ahead of print.
Jonathan G Stine1234, Ian R Schreibman13, Alison J Faust13, Jessica Dahmus1, Benjamin Stern1, Christopher Soriano1, Gloriany Rivas1, Breianna Hummer1, Scot R Kimball5, Nate R Geyer2, Vernon M Chinchilli2, Rohit Loomba67, Kathryn Schmitz2489, Christopher Sciamanna2410
Author information
1Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
2Department of Public Health Sciences, The Pennsylvania State University-College of Medicine, Hershey, Pennsylvania, USA.
3Liver Center, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
4Cancer Institute, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
5Department of Physiology, The Pennsylvania State University-College of Medicine, Hershey, Pennsylvania, USA.
6Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, San Diego, California, USA.
7NAFLD Research Center, University of California San Diego, San Diego, California, USA.
8Department of Kinesiology, The Pennsylvania State University-College of Medicine, Hershey, Pennsylvania, USA.
9Department of Physical Medicine and Rehabilitation, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
10Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
Abstract
Background and aims: NASH is a common disease associated with increased rates of thromboembolism (TE). Although exercise training can lessen thrombotic risk in patients with vascular disease, whether similar findings are observed in patients with NASH is open for study.
Approach and results: We conducted a 20-week randomized controlled clinical trial involving patients with biopsy-confirmed NASH. Patients were randomly assigned (2:1 ratio) to receive either an exercise training program or standard clinical care. The primary endpoint was change in plasminogen activator inhibitor 1 (PAI-1) level, an established thrombotic biomarker. Twenty-eight patients were randomly assigned (18 exercise training and 10 standard clinical care). PAI-1 level was significantly decreased by exercise training when compared to standard clinical care (-40 ± 100 vs. +70 ± 63 ng/ml; p = 0.02). Exercise training decreased MRI proton density fat fraction (MRI-PDFF; -4.7 ± 5.6 vs. 1.2 ± 2.8% absolute liver fat; p = 0.01); 40% of exercise subjects had a ≥30% relative reduction in MRI-PDFF (histological response threshold) compared to 13% for standard of care (p < 0.01). Exercise training improved fitness (VO2 peak, +3.0 ± 5.6 vs. -1.8 ± 5.1 ml/kg/min; p = 0.05) in comparison to standard clinical care.
Conclusions: This clinical trial showed that, independent of weight loss or dietary change, exercise training resulted in a significantly greater decrease in thrombotic risk than standard clinical care in patients with NASH, in parallel with MRI-PDFF reduction and improvement in fitness. Future studies are required to determine whether exercise training can directly impact patient outcomes and lower rates of TE.