Mechanically Ventilated PatientsPhase 2NCT00322010
Early Directed Physical Therapy in the Management of Mechanically Ventilated Patients in a Medical Intensive Care Unit
A Phase 2 study testing early PT OT in people with Mechanically Ventilated Patients, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients
- What is being tested?
- early PT OT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients
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
- Being tested
- early PT OT
- Keywords
- mechanical ventilation, physical therapy, occupational therapy, mobilization, clinical protocols, ICU acquired weakness, critical illness myopathy, muscle atrophy, intensive care unit, randomized controlled trial
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early PT OTProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Early PT OT | Experimental | 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. Receives: Procedure: early PT OT |
| Standard Care | No intervention | PT/OT delivered as ordered by the primary ICU team |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Hospital Discharge
Secondary outcomes (3)
Number of hospital days with delirium
Measured: Hospital discharge
Number of days alive and breathing without assistance (ventilator-free days)
Measured: during 28-day study period
length of stay
Measured: ICU and Hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startJun 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa
- Responsible party
- Sponsor
- Investigators
- John P Kress, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322010
- Sponsor's protocol ID
- 13766B
- Status last verified
- Mar 2014
- First submitted
- 2 May 2006
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19446324
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00322010
- Acronym / sponsor ID
- 13766B
- Conditions
- Mechanically Ventilated Patients
- Keywords
- mechanical ventilation, physical therapy, occupational therapy, mobilization, clinical protocols, ICU acquired weakness, critical illness myopathy, muscle atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- University of Iowa
- Study start
- Jun 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 4 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early PT OT | Experimental | Procedure: early PT OTEarly 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. |
| Standard Care | No intervention | –PT/OT delivered as ordered by the primary ICU team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early PT OT1. 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. | Procedure or surgery | Early PT OT |
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Derived from this study: PubMed 19446324Schweickert 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.
Related trials for Mechanically Ventilated Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Kress, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing early PT OT in people with Mechanically Ventilated Patients, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00322010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.