CClinicalTrials.gg
CompletedNCT00322010Updated Mar 18, 2014

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

A Phase 2 interventional study of early PT OT in Mechanically Ventilated Patients, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-18.

Sponsored by University of Chicago · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Mechanically Ventilated Patients

Keywords

  • mechanical ventilation
  • physical therapy
  • occupational therapy
  • mobilization
  • clinical protocols
  • ICU acquired weakness
  • critical illness myopathy
  • muscle atrophy
  • intensive care unit
  • randomized controlled trial
03

In context

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
104 participants (actual)

Study arms

  • 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

  • No intervention
    Standard Care

    PT/OT delivered as ordered by the primary ICU team

Interventions

  • Procedureearly 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.

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University of Chicago
    Chicago, Illinois 60637, United States
08

References and documents

Publications

  • 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. PubMed 19446324 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00322010
Lead sponsor
University of Chicago
Collaborators
University of Iowa
Responsible party
Sponsor
First posted
May 4, 2006
Start date
Jun 2005
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Mar 18, 2014

Study contacts

John P Kress, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion