NCT04685213

Electrical Stimulation for Critically Ill Covid-19 Patients

Electrical Stimulation Therapy for Preventing Hospital-acquired Weakness in Critically Ill COVID-19 Patients - A Proof of Concept Randomized Controlled Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase I: The purpose of this study is to test feasibility and proof-of-concept effectiveness of lower extremity electrical stimulation (EE) therapy to prevent muscular complications of COVID-19 including hospital-acquired weakness and neuropathy. This is a proof of concept randomized control trial (RCT) study for prevention. Eligible participants (n=19 anticipated) will be recruited from the Baylor St. Luke's' Medical Center (Houston, Texas). To be eligible participants should be hospitalized because of COVID-19 infection and suspected to be at risk for hospital acquired-weakness based on judgment of clinical intensivist investigators. Participants will be excluded if they are paralyzed. Other exclusion criteria include blow the knee amputation, those who have a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device; those with wound infection, and other conditions that may interfere with outcomes or increase the risk of the use EE based on judgement of clinicians. The Investigators hypothesize that implementation of EE as means of regular activation of lower extremity muscle is feasible and acceptable for the target population and would help to retain lower extremity muscle mass, lower extremity tissue oxygen saturation and perfusion, and thus reducing the severity of hospital acquired weakness and potentially improve outcomes of treatment among COVID-19 patients. Participants will be randomized to intervention (IG) or control group (CG)). The entire cohort will receive daily EE in lower extremity (e.g. Gastronemius, tibial anterior muscle) up to 1 hour. 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. 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. Outcomes will be assessed at baseline, time of discharge or 2 weeks, whichever comes first.

Conditions

• Covid19
• Muscle Atrophy
• Muscle Weakness

Interventions

Type	Name	Description
DEVICE	Electrical Stimulation	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).
DEVICE	Electrical Stimulation - Sham	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).

Timeline

• Start date: 2020-12-22
• Primary completion: 2021-03-18
• Completion: 2021-03-18
• First posted: 2020-12-28
• Last updated: 2023-02-16
• Results posted: 2022-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study