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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: Completed NA study of Sepsis, sponsored by University of Florida.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measurement of maximal isometric strength will be done by using a dynamometer.
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 |
What the finished NCT02467023 record still lists
NCT02467023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02467023's enrollment target sits among peer trials
5 90th of 90 the lowest of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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