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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients

Conditions
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Mechanically Ventilated Patients

Intervention / Treatment
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* Procedure: early PT OT


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early PT OT<br>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<br>* 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.<br>|
| No Intervention: Standard Care<br>PT/OT delivered as ordered by the primary ICU team | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, physical therapy, occupational therapy, mobilization, clinical protocols, ICU acquired weakness, critical illness myopathy, muscle atrophy, intensive care unit, randomized controlled trial