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NCT02367170 · ClinicalTrials.gov registry record · Phase 1
Project 4A: Inspiratory Muscle Training and Diaphragm Strength
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02367170: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT02367170 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02367170, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle weakness with strength training can not only improve muscle function, but also potentially blunt the inflammation and catabolism of Peristent Inflammation/Immunosuppression and Catabolism (PICS).
Primary Outcome
In this randomized, interventional study, 24 CCI patients will be assigned to either a sham group or to receive IMST for up to 28 days. Evaluation of diaphragm/inspiratory muscle strength and muscle thickness will be made with three techniques: 1) non-volitional magnetic stimulation of the phrenic nerves, 2) noninvasive measurement of diaphragm thickness with ultrasound and 3) the standard, clinical method of measuring maximal inspiratory pressure (MIP). Investigators hypothesize that IMST will
Interventions
- DRUG Midazolam
- DEVICE Inspiratory Muscle Strength Training (IMST)
- PROCEDURE Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure
- PROCEDURE Volitional Measurement of Maximal Inspiratory Pressure (MIP)
- DEVICE SHAM Inspiratory Muscle Strength Training (IMST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
Why NCT02367170 stopped before completion
NCT02367170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT02367170 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02367170 about?
NCT02367170 is a clinical study titled "Project 4A: Inspiratory Muscle Training and Diaphragm Strength". Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle weakness with strength training can not only improve muscle function, but...
What is the current status of trial NCT02367170?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2015-03. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02367170?
The interventions under investigation include: Midazolam (DRUG), Inspiratory Muscle Strength Training (IMST) (DEVICE), Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure (PROCEDURE), Volitional Measurement of Maximal Inspiratory Pressure (MIP) (PROCEDURE), SHAM Inspiratory Muscle Strength Training (IMST) (DEVICE).
Who is sponsoring clinical trial NCT02367170?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02367170's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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