AUTHOR=Zulbaran-Rojas Alejandro , Mishra Ramkinker , Rodriguez Naima , Bara Rasha O. , Lee Myeounggon , Bagheri Amir Behzad , Herlihy James P. , Siddique Muhammad , Najafi Bijan 

TITLE=Safety and efficacy of electrical stimulation for lower-extremity muscle weakness in intensive care unit 2019 Novel Coronavirus patients: A phase I double-blinded randomized controlled trial

JOURNAL=Frontiers in Medicine

VOLUME=Volume 9 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.1017371

DOI=10.3389/fmed.2022.1017371

ISSN=2296-858X

ABSTRACT=<sec><title>Background</title><p>Intensive care unit (ICU) prolonged immobilization may lead to lower-extremity muscle deconditioning among critically ill patients, particularly more accentuated in those with 2019 Novel Coronavirus (COVID-19) infection. Electrical stimulation (E-Stim) is known to improve musculoskeletal outcomes. This phase I double-blinded randomized controlled trial examined the safety and efficacy of lower-extremity E-Stim to prevent muscle deconditioning.</p></sec><sec><title>Methods</title><p>Critically ill COVID-19 patients admitted to the ICU were randomly assigned to control (CG) or intervention (IG) groups. Both groups received daily E-Stim (1 h) for up to 14 days on both gastrocnemius muscles (GNMs). The device was functional in the IG and non-functional in the CG. Primary outcomes included ankle strength (Ankle<sub>s</sub>) measured by an ankle-dynamometer, and GNM endurance (GNM<sub>e</sub>) in response to E-Stim assessed with surface electromyography (sEMG). Outcomes were measured at baseline, 3 and 9 days.</p></sec><sec><title>Results</title><p>Thirty-two (IG = 16, CG = 16) lower extremities in 16 patients were independently assessed. The mean time between ICU admission and E-Stim therapy delivery was 1.8 ± 1.9 days (<italic>p</italic> = 0.29). At 3 days, the IG showed an improvement compared to the CG with medium effect sizes for Ankle<sub>s</sub> (<italic>p</italic> = 0.06, Cohen’s <italic>d</italic> = 0.77) and GNM<sub>e</sub> (<italic>p</italic> = 0.06, <italic>d</italic> = 0.69). At 9 days, the IG GNM<sub>e</sub> was significantly higher than the CG (<italic>p</italic> = 0.04, <italic>d</italic> = 0.97) with a 6.3% improvement from baseline (<italic>p</italic> = 0.029). E-Stim did not alter vital signs (i.e., heart/respiratory rate, blood saturation of oxygen), showed no adverse events (i.e., pain, skin damage, discomfort), nor interfere with ICU standard of care procedures (i.e., mechanical ventilation, prone rotation).</p></sec><sec><title>Conclusion</title><p>This study supports the safety and efficacy of early E-Stim therapy to potentially prevent deterioration of lower-extremity muscle conditions in critically ill COVID-19 patients recently admitted to the ICU. If confirmed in a larger sample, E-Stim may be used as a practical adjunctive therapy.</p></sec><sec><title>Clinical trial registration</title><p>[<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/</ext-link>], identifier [NCT04685213].</p></sec>