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Completed

NCT Number: NCT00322010

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

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.

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Key information

Conditions

Mechanically Ventilated Patients Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early PT OT

Procedure
  • 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.

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

    Time frame: Hospital Discharge

Secondary outcomes

  1. Number of hospital days with delirium

    Time frame: Hospital discharge

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

    Time frame: during 28-day study period

  3. length of stay

    Time frame: ICU and Hospital discharge

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • University of Iowa

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 4, 2006
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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