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

NCT00322010 | Completed Phase 2

• 1 other identifier: 13766B
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  Hospital Discharge

Secondary Outcomes (3)

• Number of hospital days with delirium

  Hospital discharge

• Number of days alive and breathing without assistance (ventilator-free days)

  during 28-day study period

• length of stay

  ICU and Hospital discharge

Study Arms (2)

Early PT OT

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

PT/OT delivered as ordered by the primary ICU team

Interventions

early PT OT PROCEDURE

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.

Early PT OT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• University of Iowa: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• 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.

  PMID: 19446324 DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• John P Kress, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2006
• First Posted: May 4, 2006
• Study Start: June 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

US (1)