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

NCT00976833 | Completed DMC

• 1 other identifier: IRB00007879
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To determine whether standardized rehabilitation therapy will decrease hospital length of stay.

  5 years

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual Care

Other: Usual Care

Standardized Rehabilitation

OTHER

Intervention arm to receive Standardized Rehabilitation Therapy

Other: Standardized Rehabilitation

Interventions

Standardized Rehabilitation OTHER

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

Standardized Rehabilitation

Usual Care OTHER

Usual Physical Therapy care

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previously enrolled in TARGET STUDY
• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• Gandotra S, Lovato J, Case D, Bakhru RN, Gibbs K, Berry M, Files DC, Morris PE. Physical Function Trajectories in Survivors of Acute Respiratory Failure. Ann Am Thorac Soc. 2019 Apr;16(4):471-477. doi: 10.1513/AnnalsATS.201806-375OC.

  PMID: 30571923 DERIVED

• Morris PE, Berry MJ, Files DC, Thompson JC, Hauser J, Flores L, Dhar S, Chmelo E, Lovato J, Case LD, Bakhru RN, Sarwal A, Parry SM, Campbell P, Mote A, Winkelman C, Hite RD, Nicklas B, Chatterjee A, Young MP. Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2016 Jun 28;315(24):2694-702. doi: 10.1001/jama.2016.7201.

  PMID: 27367766 DERIVED

Study Officials

• Peter E. Morris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2015
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)