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

Phase 2CompletedNCT00322010

University of Chicago104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Mechanically Ventilated Patients

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Number of hospital days with delirium

Time frame: Hospital discharge

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

Time frame: during 28-day study period

length of stay

Time frame: ICU and Hospital discharge