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

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00322010

Collaborator

University of Iowa (Other)

104

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 1, 2005

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

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 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

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

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

Outcome Measures

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 [Hospital Discharge]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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