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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00976833
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Other: Standardized Rehabilitation Other: Usual Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standardized Rehabilitation for ICU Patients With Acute Respiratory Failure
Study Start Date : October 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Usual Care
Usual Care
 Other: Usual Care
Usual Physical Therapy care
Standardized Rehabilitation
Intervention arm to receive Standardized Rehabilitation Therapy
 Other: Standardized Rehabilitation
3 component Rehabilitation approach, Passive Range of Motion, Physical Therapy and Progressive Resistance Training


Outcome Measures
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Primary Outcome Measures :
  1. To determine whether standardized rehabilitation therapy will decrease hospital length of stay. [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Mechanically ventilated via an Endotracheal tube or Bipap
  • Lung Injury

Exclusion Criteria:

  • Previously enrolled in TARGET STUDY
  • Inability to walk without assistance prior to acute ICU illness (use of a cane or walker not exclusion)
  • Cognitive impairment prior to acute ICU illness (non-verbal)
  • Acute stroke
  • Body mass index (BMI) > 50
  • Neuromuscular disease that could impair weaning
  • Hip fracture, unstable cervical spine or pathological fracture
  • Mechanically ventilated > 80 hours
  • Current hospitalization or transferring hospital stay > 7 days
  • Ineligible cancer treatment within the last 6 month
  • Moribund
  • Do Not Resuscitate(DNR)/Do Not Intubate(DNI) on admission
  • Other Research Study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976833


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
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Principal Investigator: Peter E. Morris, MD Wake Forest University Health Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00976833    
Other Study ID Numbers: IRB00007879
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Acute Respiratory Failure
Early ICU Mobility
Early Physical Therapy
 Critical Care
Intensive Care
ICU
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases