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NCT00976833 · ClinicalTrials.gov registry record · NA
Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure
A NA study, sponsored by Wake Forest University.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT00976833 is a NA study that has completed, run by Wake Forest University. The registered enrollment target is 300 participants.
The verdict
NCT00976833, a NA study, has completed, sponsored by Wake Forest University.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
Study Summary
Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the 4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days, respectively, with median hospital costs greater than $30,000 United States. Patients with ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and reduced health-related quality of life, all of which may contribute to prolonged hospitalization and increased costs. Mechanistically, it is understood that patients with ARF demonstrate acute inflammation which may contribute to the above cited problems. While the investigators' research and that of others has shown that rehabilitation therapy can increase functional outcomes while lowering biomarkers of inflammation in the frail aged and other clinical populations, it is not known whether such rehabilitation therapy can result in improved functional capacity and functional performance and reduce inflammation in ARF patients. There is previous evidence for the feasibility and safety of rehabilitation therapy in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326 patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and administered throughout the hospitalization versus usual care (control). Standardized Rehabilitation Therapy will consist of: passive range of motion, physical therapy and progressive resistance exercise (strength training). The regimen will be administered 7 days/week by a Mobility Team consisting of a critical care nurse, physical therapist and nursing assistant. The investigators will determine whether standardized rehabilitation therapy will reduce hospital LOS, improve functional capacity and performance, improve quality of life, reduce inflammation and reduce hospital costs as compared to usual care. This study's primary objective is to
Interventions
- OTHER Usual Care
- OTHER Standardized Rehabilitation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00976833
The ClinicalTrials.gov registry entry for NCT00976833 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University, which has 100 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT00976833 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00976833 about?
NCT00976833 is a clinical study titled "Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure". Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the 4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days, respectively, with median hospital...
What is the current status of trial NCT00976833?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2009-10. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00976833?
The interventions under investigation include: Usual Care (OTHER), Standardized Rehabilitation (OTHER).
Who is sponsoring clinical trial NCT00976833?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
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