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

NCT ID: NCT00322010

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2007-10-31

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.

Conditions

Mechanically Ventilated Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

early PT OT

Intervention Type: PROCEDURE

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.

Standard Care

PT/OT delivered as ordered by the primary ICU team

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Kress, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

References

Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

Reference Type: DERIVED

PMID: 19446324 (View on PubMed)

Other Identifiers

13766B

Identifier Type: -

Identifier Source: org_study_id