Phase 1
N=19
Electrical Stimulation for Critically Ill Covid-19 Patients
Covid19 · Muscle Atrophy · Muscle Weakness
Bottom Line
View on ClinicalTrials.gov: NCT04685213 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation — 352; 323 milliVolts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Electrical Stimulation (Device); Electrical Stimulation - Sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation |
352; 323 | — |
| PRIMARY Change in Ankle Strength |
3.0; 2.1 | — |
| SECONDARY Change in Plantar Tissue Oxygen Saturation/Consumption |
69.2; 67.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT04685213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.