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NCT02467023 · ClinicalTrials.gov registry record · NA
Project 4B: Lower Extremity Strength Training in ICU Patients
A NA study of Sepsis, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT02467023 is a NA study of Sepsis that has completed, run by University of Florida. The registered enrollment target is 5 participants, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02467023, a NA study of Sepsis, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to see if electrical stimulation of the leg muscles will improve strength in patients receiving mechanical ventilation in the intensive care unit (ICU). ICU care frequently results in chronically critically ill (CCI) patients. Some CCI patients develop persistent inflammation/immunosuppression and catabolism syndrome (PICS), and they have morbid long-term outcomes. CCI patients with PICS often develop severe limb muscle atrophy, weakness and accelerated protein catabolism. Limb muscle dysfunction in PICS is due to many factors including sepsis/inflammation, proteolysis, apoptosis, and inactivity. Despite the seriousness of limb muscle weakness in CCI patients receiving mechanical ventilation, little is known about exercise strategies to treat this problem. There is limited knowledge about how strength training impacts inflammation and catabolism in CCI patients. In addition, an assessment of the effect of exercise on markers of inflammation and protein catabolism on muscle samples obtained with biopsy techniques and venous blood samples will be performed. This project will further understanding of how treating CCI-related muscle weakness with strength training cannot only improve muscle function, but also potentially blunt the inflammation and catabolism of PICS.
Conditions Studied
Interventions
- PROCEDURE Muscle Biopsy
- DEVICE Muscle stimulation with Niveus medical stimulator
- DEVICE measurement of maximal isometric twitch strength
- DRUG Muscle Biopsy Medication: Lidocaine
- DRUG Muscle Biopsy Medication: Versed
Study Locations (1)
Florida
- UF Health Shands Hospital at the University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-07-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02467023
The ClinicalTrials.gov registry entry for NCT02467023 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sepsis appearing as the primary indexed condition, and to 5 interventions - of which Muscle Biopsy is the first listed.
NCT02467023 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02467023 about?
NCT02467023 is a clinical study titled "Project 4B: Lower Extremity Strength Training in ICU Patients". The purpose of this research study is to see if electrical stimulation of the leg muscles will improve strength in patients receiving mechanical ventilation in the intensive care unit (ICU). ICU care frequently results in chronically critically ill (CCI) patients. Some CCI patients develop persisten...
What is the current status of trial NCT02467023?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2015-09. Estimated completion is 2016-07-15.
What conditions does trial NCT02467023 study?
This clinical trial studies the following conditions: Sepsis.
What interventions are being tested in trial NCT02467023?
The interventions under investigation include: Muscle Biopsy (PROCEDURE), Muscle stimulation with Niveus medical stimulator (DEVICE), measurement of maximal isometric twitch strength (DEVICE), Muscle Biopsy Medication: Lidocaine (DRUG), Muscle Biopsy Medication: Versed (DRUG).
Who is sponsoring clinical trial NCT02467023?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02467023 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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