Treatment of Critical Illness Polyneuromyopathy (Do-It-Now)
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|ClinicalTrials.gov Identifier: NCT01058421|
Recruitment Status : Completed
First Posted : January 28, 2010
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure||Procedure: intensive physical therapy Procedure: control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Trial of Intensive Physical Therapy for Patients With Acute Respiratory Failure|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||October 2015|
Experimental: Intensive physical therapy
four week intervention of daily intensive physical therapy
Procedure: intensive physical therapy
four week course of daily intensive physical therapy
|Active Comparator: control group||
Procedure: control group
four weeks of routine physical therapy
- The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10 [ Time Frame: 1 month ]The CS-PFP-10 provides an overall score and scores for upper body strength, upper body flexibility, lower body strength, balance and coordination, and endurance. The test is used to assess an individual's overall capacity to carry out activities of daily living by measuring and quantifying 10 typical activities including sweeping a floor, transferring clothes from a washer to a dryer, and carrying groceries. Tasks are quantified using time alone, time and weight, and distance. This test provides a realistic and practical measure of movement capacity and ability to accomplish sustained activity. CS-PFP-10 scores are scored from 0 to 100, with higher scores indicating better function. If patients remained in the hospital or in a long-term care facility a the time of assessment, then received a score of 0. All tests were conducted in a standardized physical therapy laboratory by a physical therapist formally trained in conducting the CS-PFP-10 and blinded to group/arm assignment.
- ICU-free Days [ Time Frame: Day 28 ]Number of ICU-free days at Day 28.
- ICU Length of Stay [ Time Frame: Total Days through Day 28 ]Median ICU length of stay through Day 28
- Mechanical Ventilation Duration [ Time Frame: up to 180 days ]The total number of ventilated days from hospital admission to extubation, death or discharge over the complete duration of study participation, up to 180 days.
- Hospital Free Days [ Time Frame: Through Day 28 ]
- Hospital Length of Stay [ Time Frame: up to 180 days ]The total number of hospital days during study participation, up to 180 days.
- Discharged to Home [ Time Frame: Through Day 28 ]Percentage of subjects discharged to home from study hospital
- Institution Free Days [ Time Frame: At Day 90 ]Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility.
- Institution Free Days [ Time Frame: Day 180 ]Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058421
|United States, Colorado|
|Medical Center of Aurora|
|Aurora, Colorado, United States, 80012|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Rose Medical Center|
|Denver, Colorado, United States, 80220|
|Swedish Medical Center|
|Englewood, Colorado, United States, 80113|
|St. Anthony Hospital|
|Lakewood, Colorado, United States, 80228|
|Principal Investigator:||Marc Moss, M.D.||University of Colorado, Denver|