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

Sponsor:	University of Chicago
Collaborator:	University of Iowa
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00322010

Purpose

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.

Condition	Intervention	Phase
Mechanically Ventilated Patients	Procedure: early PT OT	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients

Resource links provided by NLM:

MedlinePlus related topics: Delirium

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	104
Study Start Date:	June 2005
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Procedure: early PT OT Passive range of motion exercises for all limbs in patients who remain unresponsive despite sedative interruption (ten repetitions in all cardinal directions). Sessions began with active assisted and active range of motion exercises in the supine position. If tolerated, treatment is advanced to bed mobility activities, including transferring to upright sitting. Sitting balance activities are followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks. The session progresses to transfer training, and finally pre-gait exercises and ambulation. Progression of activities is dependent on patient tolerance and stability. 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.
No Intervention: Standard Care PT/OT delivered as ordered by the primary ICU team

Arms

Assigned Interventions

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.

Procedure: early PT OT

Passive range of motion exercises for all limbs in patients who remain unresponsive despite sedative interruption (ten repetitions in all cardinal directions).
Sessions began with active assisted and active range of motion exercises in the supine position.
If tolerated, treatment is advanced to bed mobility activities, including transferring to upright sitting.
Sitting balance activities are followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
The session progresses to transfer training, and finally pre-gait exercises and ambulation.
Progression of activities is dependent on patient tolerance and stability.
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.

No Intervention: Standard Care

PT/OT delivered as ordered by the primary ICU team

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322010

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

University of Iowa

Investigators

Principal Investigator:

John P Kress, MD

University of Chicago

More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	John P. Kress MD, University of Chicago
ClinicalTrials.gov Identifier:	NCT00322010 History of Changes
Other Study ID Numbers:	13766B
Study First Received:	May 2, 2006
Last Updated:	March 5, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

mechanical ventilation
physical therapy
occupational therapy
mobilization
clinical protocols

ICU acquired weakness
critical illness myopathy
muscle atrophy
intensive care unit
randomized controlled trial

ClinicalTrials.gov processed this record on February 09, 2012