Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00322010
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
University of Chicago

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Mechanically Ventilated Patients Procedure: early PT OT Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
  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.
No Intervention: Standard Care
PT/OT delivered as ordered by the primary ICU team


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of hospital days with delirium [ Time Frame: Hospital discharge ]
  2. Number of days alive and breathing without assistance (ventilator-free days) [ Time Frame: during 28-day study period ]
  3. length of stay [ Time Frame: ICU and Hospital discharge ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00322010


Locations
Layout table for location information
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
University of Iowa
Investigators
Layout table for investigator information
Principal Investigator: John P Kress, MD University of Chicago
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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
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