Early Directed Physical Therapy in the Management of Mechanically Ventilated Patients in a Medical Intensive Care Unit

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. Read our disclaimer for details. Identifier: NCT00322010
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : March 18, 2014
University of Iowa
Information provided by (Responsible Party):
University of Chicago

May 2, 2006
May 4, 2006
March 18, 2014
June 2005
October 2007   (Final data collection date for primary outcome measure)
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 ]
  • Neuro muscular weakness (NMW) as measured by clinical exam & hand grip monitor
  • Ability to perform activities of daily living (ADL's)
  • ICU DC strength testing
  • Hospital DC strength testing
  • Blood testing for NMW markers
  • 6 month follow up - mortality, ability to perform ADL's, return to work
Complete list of historical versions of study NCT00322010 on Archive Site
  • 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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Early Directed Physical Therapy in the Management of Mechanically Ventilated Patients in a Medical Intensive Care Unit
A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients
To study all ICU patients with an independent baseline functional status, who experience a critical illness requiring intubation and mechanical ventilation, evaluating the role of protocol-directed, early physical and occupational therapy on the incidence of critical illness associated functional debilitation. Our goal is to hasten the recovery of independent physical functioning as well as to reduce ICU delirium in the group of patients who begin this intervention from the earliest hours of ventilator dependence.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Mechanically Ventilated Patients
Procedure: early PT OT
  1. Passive range of motion exercises for all limbs in patients who remain unresponsive despite sedative interruption (ten repetitions in all cardinal directions).
  2. Sessions began with active assisted and active range of motion exercises in the supine position.
  3. If tolerated, treatment is advanced to bed mobility activities, including transferring to upright sitting.
  4. Sitting balance activities are followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
  5. The session progresses to transfer training, and finally pre-gait exercises and ambulation.
  6. Progression of activities is dependent on patient tolerance and stability.
  7. Therapy intervention continues on a daily basis throughout the patient's hospital stay until he/she returns to prior level of function or is discharged.
  • 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.
    Intervention: Procedure: early PT OT
  • No Intervention: Standard Care
    PT/OT delivered as ordered by the primary ICU team
Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2007
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Patients intubated and mechanical ventilated for < 72 hours
  2. Age > 18 years
  3. 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

  1. Rapidly evolving neurological/neuromuscular disease
  2. Cardiac arrest
  3. Irreversible conditions with six month mortality estimated at > 50%
  4. Elevated intracranial pressure
  5. Multiple absent limbs (precluding complete musculoskeletal examination)
  6. Enrollment in another trial
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Chicago
University of Chicago
University of Iowa
Principal Investigator: John P Kress, MD University of Chicago
University of Chicago
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP