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NCT04685213 · ClinicalTrials.gov registry record · Phase 1

Electrical Stimulation for Critically Ill Covid-19 Patients

A Phase 1 study of Covid19 and Muscle Weakness, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target
1
Study location

NCT04685213 is a Phase 1 study of Covid19 and Muscle Weakness that has completed, run by Baylor College of Medicine. The registered enrollment target is 19 participants, below the 2,702-participant average among 94 other Covid19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04685213, a Phase 1 study of Covid19 and Muscle Weakness, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DEVICE Electrical Stimulation
  • DEVICE Electrical Stimulation - Sham

Study Locations (1)

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2020-12-22
Est. Completion 2021-03-18
Phase Phase 1

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT04685213

The ClinicalTrials.gov registry entry for NCT04685213 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,702-participant average among 94 other Covid19 trials with a reported enrollment target (99% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Covid19 appearing as the primary indexed condition, and to 2 interventions - of which Electrical Stimulation is the first listed.

NCT04685213 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04685213 about?

NCT04685213 is a clinical study titled "Electrical Stimulation for Critically Ill Covid-19 Patients". 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 ...

What is the current status of trial NCT04685213?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2020-12-22. Estimated completion is 2021-03-18.

What conditions does trial NCT04685213 study?

This clinical trial studies the following conditions: Covid19, Muscle Weakness, Muscle Atrophy.

What interventions are being tested in trial NCT04685213?

The interventions under investigation include: Electrical Stimulation (DEVICE), Electrical Stimulation - Sham (DEVICE).

Who is sponsoring clinical trial NCT04685213?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04685213 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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