Phase 2 N=19 Randomized Double-blind Supportive Care

Electrical Stimulation for Critically Ill Post-Covid-19 Patients

COVID-19 · Muscle Atrophy · Muscle Weakness

Bottom Line

View on ClinicalTrials.gov: NCT05198466 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation — 363.04; 359.55 miliVolts

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Electrical Stimulation (Device); Electrical Stimulation - Sham (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation	363.04; 359.55	—
PRIMARY Ankle Strength	8.5; 7.9	—
SECONDARY Plantar Oxyhemoglobin	.57; .54	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05198466). 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.