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

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standardized Rehabilitation
Usual Care
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Acute Respiratory Failure, Early ICU Mobility, Early Physical Therapy, Critical Care, Intensive Care, ICU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Usual Care

Standardized Rehabilitation

Arm Description

Usual Care

Intervention arm to receive Standardized Rehabilitation Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2009
Last Updated
August 8, 2018
Sponsor
Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT00976833
Brief Title
Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure
Official Title
Standardized Rehabilitation for ICU Patients With Acute Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Acute Respiratory Failure, Early ICU Mobility, Early Physical Therapy, Critical Care, Intensive Care, ICU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual Care
Arm Title
Standardized Rehabilitation
Arm Type
Other
Arm Description
Intervention arm to receive Standardized Rehabilitation Therapy
Intervention Type
Other
Intervention Name(s)
Standardized Rehabilitation
Intervention Description
3 component Rehabilitation approach, Passive Range of Motion, Physical Therapy and Progressive Resistance Training
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Physical Therapy care
Primary Outcome Measure Information:
Title
To determine whether standardized rehabilitation therapy will decrease hospital length of stay.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E. Morris, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30571923
Citation
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.
Results Reference
derived
PubMed Identifier
27367766
Citation
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.
Results Reference
derived

Learn more about this trial

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

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