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Early Mobilization in the ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01777035
Recruitment Status : Recruiting
First Posted : January 28, 2013
Last Update Posted : October 3, 2019
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.

Condition or disease Intervention/treatment Phase
Respiratory Failure Other: early PT OT Not Applicable

Detailed Description:
Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Mobilization in the ICU
Study Start Date : July 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Early physical therapy(PT) occupational therapy (OT)
Early PT OT assessments begin on first day of study. Therapy delivered by a team consisting of physical and occupational therapists and coordinated with daily sedative interruption
Other: early PT OT
  1. Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption.
  2. active assisted ROM in supine position.
  3. treatment is advanced to bed mobility activities
  4. sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
  5. progression to transfer training, and finally pre-gait training and ambulation.
  6. progression of activities dependent on patient tolerance and stability
  7. therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.

No Intervention: standard care
PT OT delivered as ordered by the primary ICU team

Primary Outcome Measures :
  1. presence of cognitive impairment [ Time Frame: within the first 30 days after ICU admission ]
  2. presence of cognitive impairment [ Time Frame: up to 1 year post discharge ]

Secondary Outcome Measures :
  1. cognitive test score [ Time Frame: up to 1 year post discharge ]

    includes variables

    1. orientation
    2. attention
    3. memory
    4. reasoning
    5. executive function

  2. institution free days [ Time Frame: up to 1 yr post discharge ]
    number of days not requiring inpatient admission

  3. Insulin Resistance [ Time Frame: day 3 of mechanical ventilation ]
    Measuring insulin resistance and glycemic control in patients who are still mechanically ventilated on third day of enrollment in the study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Intubated and MV > 24, < 96 hours
  • Baseline Barthel Index Functional Score > 70, functional at home

Exclusion Criteria:

  • Rapidly changing neurological conditions (e.g. stroke)
  • Cardiac arrest as cause for respiratory failure
  • Elevated intracranial pressure
  • Pregnancy (due to inability to provide continuous fetal monitoring)
  • Terminal condition (life expectancy < 6 months)
  • Traumatic brain injury, multiple limb fractures, pelvic fractures,
  • Severe chronic pain syndrome on admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01777035

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Contact: John P Kress, MD 773-702-6404
Contact: Anne Pohlman, MSN 773-702-3804

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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Anne Pohlman, MSN    773-702-3804   
Principal Investigator: John P Kress, MD         
Sub-Investigator: Bhakti Patel, MD         
Sponsors and Collaborators
University of Chicago
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Principal Investigator: John P Kress, MD University of Chicago

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Chicago Identifier: NCT01777035     History of Changes
Other Study ID Numbers: 11-0218
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Keywords provided by University of Chicago:
mechanical ventilation
physical therapy
occupational therapy
ICU acquired weakness
critical illness myopathy
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases