Effects of neuromuscular electrical stimulation therapy on physical function in patients with COVID-19 associated pneumonia: Study protocol of a randomized controlled trial

Abstract

Purpose Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients during and/or after intensive care unit (ICU) stay. The overall objective of this study is to evaluate the NMES effectiveness to counteract the post-ICU impairment in physical function of COVID-19 patients. The specific aim of this manuscript is to describe the study design, protocol, content of interventions, primary and secondary outcomes and to discuss the clinical rehabilitation impact of the expected experimental results. Methods This prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. Patients are randomized to a control group (routine physical therapy for 3 weeks) or a NMES group (routine physical therapy plus NMES of quadriceps and gastrocnemius muscles for 3 weeks). The primary outcome is physical performance assessed through the Short Physical Performance Battery (SPPB). Secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. The SPBB and walking performance are assessed once (after the intervention), while all other outcomes are assessed twice (before and after the intervention). Conclusion NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. Therefore, proving the effectiveness of NMES therapy for physical and muscle function in COVID-19 patients could support its systematic incorporation in post-ICU rehabilitation protocols of patients presenting with post-intensive care syndrome.

Proposed subtypes of post‐COVID‐19 syndrome (or long‐COVID) and their respective potential therapies

“…However, a meta‐analysis of 10 RCTs has reported that post‐ICU physical rehabilitation may not necessarily improve health and mental quality of life at 6‐ to 12‐month 136 . Nonetheless, more RCTs are ongoing that sought to test other potential non‐pharmaceutical therapies (e.g., neuromuscular electrical stimulation, virtual reality and rehabilitation programs) for post‐ICU survivors of COVID‐19 137–141 …”

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

“…Today, this technology has been demonstrated to improve muscle strength in ICU COVID-19 patients ( 21 ). However, there is still a lack of randomized studies ( 22 ) to confirm its efficacy. Thus, it is unclear whether this adjunctive therapy prevents lower-extremity muscle deconditioning in ICU COVID-19 patients.…”

Neuromuscular Electrical Stimulation (NMES) as an Add-on Therapy for the Improvement of Dyspnea in Patients with Post-Covid Syndrome: a Protocol for a Phase II Randomized, Non-Pharmacological Intervention-Controlled, Double-Blind Study.

“…In previous RCTs, NMES has shown to be a valuable, straightforward, and non-invasive adjunct therapy to pulmonary rehabilitation for COPD patients (Bourjeily-Habr et al, 2002). It has also been shown to improve physical and functional performance in patients with pneumonia (Minetto et al, 2021), and post-intensive care syndrome (Minetto et al, 2021). However, no conclusive recommendations have been provided to support NMES as a non-pharmacological intervention for patients with PCS.…”

“…To date, physical therapy is the standard care for patients with PCS, and no conclusive recommendations have been provided to support other nonpharmacological interventions for this condition. In addition, it has been hypothesized that Neuromuscular Electrical Stimulation (NMES) is a safe and effective non-pharmacological intervention for improving muscle weakness in different pulmonary diseases (Minetto et al, 2021).…”