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

This study has been completed.
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
John Kress, University of Chicago
ClinicalTrials.gov Identifier:
NCT00322010
First received: May 2, 2006
Last updated: June 19, 2012
Last verified: June 2012
History of Changes

May 2, 2006
June 19, 2012
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 ] [ Designated as safety issue: No ]
  • Ability to perform activities of daily living (ADL's)
  • Neuro muscular weakness (NMW) as measured by clinical exam & hand grip monitor
  • 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 ClinicalTrials.gov Archive Site
  • Number of hospital days with delirium [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Number of days alive and breathing without assistance (ventilator-free days) [ Time Frame: during 28-day study period ] [ Designated as safety issue: No ]
  • length of stay [ Time Frame: ICU and Hospital discharge ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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. Epub 2009 May 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00322010
13766B
No
John Kress, University of Chicago
University of Chicago
University of Iowa
Principal Investigator: John P Kress, MD University of Chicago
University of Chicago
June 2012

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