Early Directed Physical Therapy in the Management of Mechanically Ventilated Patients in a Medical Intensive Care Unit
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ClinicalTrials.gov Identifier: NCT00322010 |
Recruitment Status :
Completed
First Posted : May 4, 2006
Last Update Posted : March 18, 2014
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Condition or disease | Intervention/treatment | Phase |
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Mechanically Ventilated Patients | Procedure: early PT OT | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |
Arm | Intervention/treatment |
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Experimental: Early PT OT
Early PT/OT Therapy assessments to begin on the first day that consent is obtained. Therapy is delivered by a team consisting of a physical and occupational therapist and coordinated with daily sedative interruption.
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Procedure: early PT OT
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No Intervention: Standard Care
PT/OT delivered as ordered by the primary ICU team
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- Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation [ Time Frame: Hospital Discharge ]
- Number of hospital days with delirium [ Time Frame: Hospital discharge ]
- Number of days alive and breathing without assistance (ventilator-free days) [ Time Frame: during 28-day study period ]
- length of stay [ Time Frame: ICU and Hospital discharge ]

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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
- Patients intubated and mechanical ventilated for < 72 hours
- Age > 18 years
- Baseline independent functional status as assessed by a Barthel Index score > 70 collected from a proxy reflecting baseline health 2 weeks prior to critical illness
Exclusion Criteria
- Rapidly evolving neurological/neuromuscular disease
- Cardiac arrest
- Irreversible conditions with six month mortality estimated at > 50%
- Elevated intracranial pressure
- Multiple absent limbs (precluding complete musculoskeletal examination)
- Enrollment in another trial

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 ClinicalTrials.gov identifier (NCT number): NCT00322010
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | John P Kress, MD | University of Chicago |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00322010 |
Other Study ID Numbers: |
13766B |
First Posted: | May 4, 2006 Key Record Dates |
Last Update Posted: | March 18, 2014 |
Last Verified: | March 2014 |
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