Early Mobilization in the ICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-19

Study Completion Date

2022-01-14

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 long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.

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Detailed Description

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Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early physical therapy(PT) occupational therapy (OT)

Early PT OT assessments begin on first day of study. Therapy delivered by a team consisting of physical and occupational therapists and coordinated with daily sedative interruption

Group Type EXPERIMENTAL

early PT OT

Intervention Type OTHER

1. Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption.
2. active assisted ROM in supine position.
3. treatment is advanced to bed mobility activities
4. sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
5. progression to transfer training, and finally pre-gait training and ambulation.
6. progression of activities dependent on patient tolerance and stability
7. therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.

standard care

PT OT delivered as ordered by the primary ICU team

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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early PT OT

1. Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption.
2. active assisted ROM in supine position.
3. treatment is advanced to bed mobility activities
4. sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
5. progression to transfer training, and finally pre-gait training and ambulation.
6. progression of activities dependent on patient tolerance and stability
7. therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Intubated and MV \> 24, \< 96 hours
* Baseline Barthel Index Functional Score \> 70, functional at home

Exclusion Criteria

* Rapidly changing neurological conditions (e.g. stroke)
* Cardiac arrest as cause for respiratory failure
* Elevated intracranial pressure
* Pregnancy (due to inability to provide continuous fetal monitoring)
* Terminal condition (life expectancy \< 6 months)
* Traumatic brain injury, multiple limb fractures, pelvic fractures,
* Severe chronic pain syndrome on admission

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No