Nonalcoholic steatohepatitis Fitness Intervention in Thrombosis (NASHFit): Study protocol for a randomized controlled trial of a supervised aerobic exercise program to reduce elevated clotting risk in patients with NASH

Stine, Jonathan G.; Schreibman, Ian; Navabi, Seyedehsan; Kang, Mitchell; Dahmus, Jessica; Soriano, Christopher; Rivas, Gloriany; Hummer, Breianna; Beyer, Megan; Tressler, Heather; Kimball, Scot R.; Patterson, Andrew D.; Schmitz, Kathryn H.; Sciamanna, Christopher N.

doi:10.1016/j.conctc.2020.100560

Cited by 17 publications

(14 citation statements)

References 91 publications

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“…Because institutional restrictions prevented in-person clinical trial activity at the height of the pandemic, we adapted an existing clinical trial that was actively recruiting patients (prior to COVID-19 restrictions, 25 patients were recruited under the original clinical trial protocol) [ 4 ] and delivered 20 weeks of moderate-intensity aerobic training 5 days a week under real-time direct supervision by an exercise physiologist using an Institutional Review Board–approved audio–visual (A–V) telehealth platform with 2-way communication. Aerobic training was completed by walking outdoors or using a home treadmill.…”

Section: Methodsmentioning

confidence: 99%

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Utilization of a Directly Supervised Telehealth-Based Exercise Training Program in Patients With Nonalcoholic Steatohepatitis: Feasibility Study

Motz¹,

Faust²,

Dahmus³

et al. 2021

JMIR Form Res

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Background Most patients with nonalcoholic fatty liver disease (NAFLD) are physically inactive despite the well-known benefits of physical activity. Telehealth offers promise as a novel way to deliver an exercise training program and increase physical activity. However, the feasibility, safety, and efficacy of telehealth-based exercise programs is unknown in patients with NAFLD. Objective The aim of this study was to determine the feasibility of a directly supervised exercise training program delivered exclusively with telehealth to patients with nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD. Methods In response to COVID-19 research restrictions, we adapted an existing clinical trial and delivered 20 weeks of moderate-intensity aerobic training 5 days a week under real-time direct supervision using an audio–visual telehealth platform. Aerobic training was completed by walking outdoors or using a home treadmill. Fitness activity trackers with heart rate monitors ensured exercise was completed at the prescribed intensity with real-time feedback from an exercise physiologist. Results Three female patients with biopsy-proven NASH were enrolled with a mean age of 52 (SD 14) years. The mean body mass index was 31.9 (SD 5.1) kg/m2. All patients had metabolic syndrome. All patients completed over 80% of exercise sessions (mean 84% [SD 3%]) and no adverse events occurred. Body weight (mean –5.1% [SD 3.7%]), body fat (mean –4.4% [SD 2.3%]), and waist circumference (mean –1.3 in. [SD 1.6 in.]) all improved with exercise. The mean relative reduction in magnetic resonance imaging-proton density fat fraction (MRI-PDFF) was 35.1% (SD 8.8%). Mean reductions in hemoglobin A1c and Homeostatic Model Assessment for Insulin Resistance were also observed (–0.5% [SD 0.2%] and –4.0 [SD 1.2], respectively). The mean peak oxygen consumption (VO2peak) improved by 9.9 (SD 6.6) mL/kg/min. Conclusions This proof-of-concept study found that supervised exercise training delivered via telehealth is feasible and safe in patients with NASH. Telehealth-based exercise training also appears to be highly efficacious in patients with NASH, but this will need to be confirmed by future large-scale trials. Trial Registration ClinicalTrials.gov NCT03518294; https://clinicaltrials.gov/ct2/show/NCT03518294

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Section: Methodsmentioning

confidence: 99%

“…Feasibility was defined as completing 80% or more of exercise sessions [ 5 ]. Secondary clinical outcomes were captured according to the existing study protocol [ 4 ]. Patients also received dietary counseling according to the original study protocol which allowed for telehealth as a way to provide the nutritional feedback.…”

Section: Methodsmentioning

confidence: 99%

Utilization of a Directly Supervised Telehealth-Based Exercise Training Program in Patients With Nonalcoholic Steatohepatitis: Feasibility Study

Motz¹,

Faust²,

Dahmus³

et al. 2021

JMIR Form Res

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“…A complete list of the trial endpoints was published. [21] Modifications to the original study protocol are also included in the Supplementary Appendix of the Supporting Information, including the provision to complete exercise sessions using telehealth during the COVID-19 pandemic based on local research restrictions.…”

Section: Endpointsmentioning

confidence: 99%

NASHFit: A randomized controlled trial of an exercise training program to reduce clotting risk in patients with NASH

et al. 2022

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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. Twentyeight 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;

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“…Additionally, many subjects included had either NAFL (19%) or very early‐stage NASH (37% NAFLD Activity Score [NAS] < 5), which again limits expected histologic improvement. Restricting to only subjects with NASH and fibrosis stage 1‐3 or performing subgroup analysis with these criteria would significantly strengthen the authors’ conclusions 4,5 . Additionally, were subjects on pharmacologic treatment included?…”

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confidence: 90%

Letter: proving the benefit of exercise intervention in non‐alcoholic fatty liver disease

Stine

Schmitz

2020

Aliment Pharmacol Ther

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Nonalcoholic steatohepatitis Fitness Intervention in Thrombosis (NASHFit): Study protocol for a randomized controlled trial of a supervised aerobic exercise program to reduce elevated clotting risk in patients with NASH

Cited by 17 publications

References 91 publications

Utilization of a Directly Supervised Telehealth-Based Exercise Training Program in Patients With Nonalcoholic Steatohepatitis: Feasibility Study

Utilization of a Directly Supervised Telehealth-Based Exercise Training Program in Patients With Nonalcoholic Steatohepatitis: Feasibility Study

NASHFit: A randomized controlled trial of an exercise training program to reduce clotting risk in patients with NASH

Letter: proving the benefit of exercise intervention in non‐alcoholic fatty liver disease

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