Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With

Status Completed

Clinical Trial 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 determine whether standardized rehabilitation therapy will decrease hospital length of stay.

Hypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital length of stay for patients with Acute Respiratory Failure.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Acute Respiratory Failure
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency

Clinical Trial Details

NCT number	NCT00976833
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase	N/A
Start date	October 2009
Completion date	June 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms