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NCT04685213 · ClinicalTrials.gov registry record · Phase 1
Electrical Stimulation for Critically Ill Covid-19 Patients
A Phase 1 study of COVID-19 and Muscle Weakness, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04685213: Completed Phase 1 study of COVID-19 and Muscle Weakness, sponsored by Baylor College of Medicine.
NCT04685213 is a Phase 1 study of COVID-19 and Muscle Weakness that has completed, run by Baylor College of Medicine. The registered enrollment target is 19 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04685213, a Phase 1 study of COVID-19 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.
Primary Outcome
Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Conditions Studied
Interventions
- DEVICE Electrical Stimulation
- DEVICE Electrical Stimulation - Sham
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-12-22 |
| Est. Completion | 2021-03-18 |
| Phase | Phase 1 |
What the finished NCT04685213 record still lists
NCT04685213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Electrical Stimulation is the first listed.
NCT04685213 reports a single indexed study location in 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: COVID-19, 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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Where NCT04685213's enrollment target sits among peer trials
19 286th of 298 higher than 13 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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