Electrical Stimulation for Critically Ill Post-Covid-19 Patients
Purpose
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.
Conditions
- COVID-19
- Muscle Atrophy
- Muscle Weakness
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- 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.
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
- Masking Description
- Devices may be active or sham.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Active E-Stim |
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
|
|
Sham Comparator Electrical Stimulation - Sham |
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). |
|
Recruiting Locations
More Details
- NCT ID
- NCT05198466
- Status
- Completed
- Sponsor
- Baylor College of Medicine
Detailed Description
20 subjects that were hospitalized due to severe COVID-19 infection and present neuromuscular complications (i.e., hospital acquired weakness due to neuromyopathy) will be recruited after the first phase of this study is completed. Unlike Phase I (study for prevention), this is a proof of concept randomized control trial (RCT) study for recovery. The patients will be recruited from the COVID-19 Clinic at Baylor College of Medicine and will begin the study after being diagnosed with neuromyopathy due to prolonged hospitalization for COVID-19. This will be performed by a critical care and pulmonary specialist at the BCM COVID-19 Clinic. The entire cohort will receive daily electrical stimulation in lower extremity (e.g. Gastrocnemius, tibial anterior muscle) up to 1 hour to recover from Neuromyopathy complications and prolonged hospital stay. Participants will be randomized to intervention (IG) or control group (CG)). EE therapy will be provided using a bio-electric stimulation technology (BEST) platform (Tennant Biomodulator PRO®, AVAZZIA, Inc.). The EE device will be functional for IG and non-functional for CG. In addition to taking the device home to deliver electrical stimulation themselves, the patients will attend a weekly assessment at the McNair Campus for up to 4 weeks. The primary outcomes include between group difference and change from the baseline in muscle endurance, muscle strength, lower extremity tissue oxygen saturation, neuropathy, and muscle atrophy.