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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Peter E. Morris, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00976833
First received: September 11, 2009
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Acute Respiratory Failure
Other: Standardized Rehabilitation
Other: Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Standardized Rehabilitation for ICU Patients With Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • To determine whether standardized rehabilitation therapy will decrease hospital length of stay. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 326
Study Start Date: October 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976833

Contacts
Contact: Peter E. Morris, MD 336-716-1210 pemorris@wakehealth.edu
Contact: Michael J. Berry, Ph.D. 336-758-5847 berry@wfu.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Peter Morris, MD    336-716-1210      
Principal Investigator: Peter E. Morris, MD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Peter E. Morris, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Peter E. Morris, MD, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00976833     History of Changes
Other Study ID Numbers: IRB00007879
Study First Received: September 11, 2009
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Acute Respiratory Failure
Early ICU Mobility
Early Physical Therapy
Critical Care
Intensive Care
ICU

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014