Electrical Stimulation for Critically Ill Covid-19 Patients
Condition: Covid19; Muscle Atrophy; Muscle Weakness
MeSH terms: COVID-19; Muscle Weakness; Muscular Atrophy; Asthenia
Intervention: Electrical Stimulation; Electrical Stimulation - Sham
Intervention description: Subjects will receive an active electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).; Subjects will receive a sham electrical stimulation device to wear for 1 hour daily up to two weeks or until hospital discharge, whichever came first (phase I).
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily electrical stimulation (EE) in lower extremity (e.g. Gastronemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG.
Phase I will include patients (n=19) admitted to the hospital due to severe COVID-19 infection. The time frame for therapy will be 2 weeks or until hospital discharge, whichever comes first.
Masking: Double (Participant, Care Provider)
Masking description: Devices may be active or sham.
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: electrical stimulation; skin perfusion; Muscle dysfunction

Summary:

      Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized
      patients, who often require prolonged bed-rest or paralytics for an extended period of time
      in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss
      of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment
      and complications post-hospital discharge. Physical therapy and in-hospital mobility program
      may reduce the incident of hospital-acquired weakness, but they are often impractical for
      COVID-19 patients. In particular, conventional mobility programs are challenging for those
      who are being treated in an intensive Care Unit. The purpose of this study is to test
      feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical
      stimulation (EE) therapy, as a practical solution to address lower extremity muscle
      deconditioning, to address chronic consequences of COVID-19 including hospital-acquired
      weakness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COVID-19 test positive critically ill patients in need of assisted ventilation
             requiring care in the intensive care unit

          -  COVID-19 test positive critically ill patients in need of assisted ventilation
             requiring prolonged care in the hospital

        Exclusion Criteria:

          -  Paralyzed patients (i.e., rocuronium, cisatracurium) at the moment of enrollment

          -  Patients under vasopressor therapy (i.e., norepinephrine, epinephrine, vasopressin) at
             the moment of enrollment

          -  Patients expected to be discharged in the next 24 hours

          -  Patient has a demand-type cardiac pacemaker, implanted defibrillator or other
             implanted electronic device.

          -  Active wound infection

          -  Below the knee amputations

          -  Based on the clinicians decision whether the patient is eligible for the study