Electrical Stimulation for Critically Ill Post-Covid-19 Patients
Condition: COVID-19; 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 for 4 weeks (phase II).; Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Phase: Phase 2
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. Gastrocnemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG.
Phase II will include previously hospitalized patients (n=20) who had recover from severe COVID-19 infection, but present persistent neuromuscular sequelae. This will be performed in an outpatient clinic. The time frame will be 4 weeks.
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:

          -  Post-COVID-19 patients who required hospitalization due to COVID-19 severe infection.

          -  Post-COVID-19 patients who required hospitalization and present neuromuscular sequelae
             due to COVID-19 severe infection.

        Exclusion Criteria:

          -  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.