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

Standardized Rehabilitation for ICU Patients With Acute Respiratory Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00976833
Enrollment
300
Registered
2009-09-14
Start date
2009-10-31
Completion date
2015-06-30
Last updated
2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Acute Respiratory Failure, Early ICU Mobility, Early Physical Therapy, Critical Care, Intensive Care, ICU

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.

Interventions

3 component Rehabilitation approach, Passive Range of Motion, Physical Therapy and Progressive Resistance Training

OTHERUsual Care

Usual Physical Therapy care

Sponsors

Wake Forest University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
To determine whether standardized rehabilitation therapy will decrease hospital length of stay.5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026