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

NCT ID: NCT00976833

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

Usual Care

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual Physical Therapy care

Standardized Rehabilitation

Intervention arm to receive Standardized Rehabilitation Therapy

Group Type: OTHER

Standardized Rehabilitation

Intervention Type: OTHER

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

Interventions

Standardized Rehabilitation

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

Intervention Type: OTHER

Usual Care

Usual Physical Therapy care

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter E. Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30571923 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27367766 (View on PubMed)

Other Identifiers

IRB00007879

Identifier Type: -

Identifier Source: org_study_id