Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure
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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 |
- 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 |
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| Contact: Peter E. Morris, MD | 336-716-8898 | pemorris@wfubmc.edu |
| Contact: Michael J. Berry, Ph.D. | 336-758-5847 | berrry@wfu.edu |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston Salem, North Carolina, United States, 27157 | |
| Contact: Peter Morris, MD 336-716-8898 | |
| Principal Investigator: Peter E. Morris, MD | |
| Principal Investigator: | Peter E. Morris, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Peter E. Morris, MD, Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00976833 History of Changes |
| Other Study ID Numbers: | IRB00007879 |
| Study First Received: | September 11, 2009 |
| Last Updated: | October 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
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 Respiratory Tract Diseases Respiration Disorders |
ClinicalTrials.gov processed this record on May 21, 2013