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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: Completed NA study, sponsored by Wake Forest University.
NCT00976833 is a NA study that has completed, run by Wake Forest University. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00976833 record still lists
NCT00976833 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT00976833 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00976833's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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