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

Abstract

BackgroundIntensive 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.MethodsCritically 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 (Ankles) measured by an ankle-dynamometer, and GNM endurance (GNMe) in response to E-Stim assessed with surface electromyography (sEMG). Outcomes were measured at baseline, 3 and 9 days.ResultsThirty-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 (p = 0.29). At 3 days, the IG showed an improvement compared to the CG with medium effect sizes for Ankles (p = 0.06, Cohen’s d = 0.77) and GNMe (p = 0.06, d = 0.69). At 9 days, the IG GNMe was significantly higher than the CG (p = 0.04, d = 0.97) with a 6.3% improvement from baseline (p = 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).ConclusionThis 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.Clinical trial registration[https://clinicaltrials.gov/], identifier [NCT04685213].

Electrical stimulation to regain lower extremity muscle perfusion and endurance in patients with post‐acute sequelae of SARS CoV‐2: A randomized controlled trial

“…This suggests that only the intervention group regained muscle endurance as a response to E-Stim therapy. Our results are also in line with our previous study, which reported improved muscle endurance in response to lower extremity E-Stim therapy (Zulbaran-Rojas et al, 2022).…”

“…An additional objective measure to assess the improvement in muscle endurance is through iEMG analysis (Zulbaran‐Rojas et al, 2022), which reflects increased muscle fiber activation (Cettolo et al, 2007). In our overall cohort, at baseline, we observed a decline in muscle endurance during the 1 h E‐Stim session (Figure 4a), which was expected given the impaired oxygen metabolism seen in PASC patients, leading to faster muscle fatigue (Nosaka et al, 2011).…”

“…This therapy has been shown to improve muscle endurance in hospitalized or limited‐mobility patients (Burgess et al, 2021), to reduce muscle loss (Burgess et al, 2021; Leite et al, 2018), and improve tissue perfusion (Zulbaran‐Rojas et al, 2021). Additionally, E‐Stim has been effective in improving muscle strength (Righetti et al, 2022) and endurance (Zulbaran‐Rojas et al, 2022) in severe acute COVID‐19 patients. However, the long‐term effects of E‐Stim on muscle perfusion have not been well studied, and its utility for the recovery of individuals with musculoskeletal PASC has not been explored.…”

Effects of acute phase intensive electrical muscle stimulation in COVID-19 patients requiring invasive mechanical ventilation: an observational case-control study

“…There have been few studies of the effects of EMS therapy in patients with COVID-19. In a previous RCT, application of EMS to the gastrocnemius muscles for up to 14 days was accompanied only by improvements in lower extremity muscle condition, e.g., ankle muscle strength and endurance, in critically ill patients with COVID-19 admitted to the ICU 30 . In another study, application of EMS to the quadriceps femoris muscles for 7 consecutive days only increased muscle strength assessed according to the MRC score and function in patients with severe COVID-19 during ICU admission, although they did not include a control group for comparison 31 .…”

Rehabilitation and COVID-19: systematic review by Cochrane Rehabilitation

“…More than half of the studies (57%, N=30, 2075 participants) included adults with PCC, 42 - 46 , 48 - 51 , 53 , 56 , 57 , 59 - 62 , 64 , 66 , 67 , 70 - 72 , 74 - 76 , 81 , 83 , 85 , 88 , 89 followed by adults with non-severe (34%, N.=18, 1489 participants), severe (6%, N.=3, 230 participants) 39 , 63 , 86 and critical COVID-19 (4%, N.=2, 88 participants). 41 , 90 …”