N/A
N=120
Treatment of Critical Illness Polyneuromyopathy
Acute Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT01058421 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: 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 — 19.0; 20.9 score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intensive physical therapy (Procedure); control group (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
19.0; 20.9 | — |
| SECONDARY ICU-free Days |
13; 11 | — |
| SECONDARY ICU Length of Stay |
15; 16 | — |
| SECONDARY Mechanical Ventilation Duration |
10; 10 | — |
| SECONDARY Hospital Free Days |
7; 7 | — |
| SECONDARY Hospital Length of Stay |
21; 21 | — |
| SECONDARY Discharged to Home |
51; 49 | — |
| SECONDARY Institution Free Days |
151; 146 | — |
| SECONDARY Institution Free Days |
151; 146 | — |
Summary
Acute respiratory failure is a heterogeneous disorder that results in more than 300,000 Americans requiring admission to an intensive care unit for invasive mechanical ventilatory support each year. Though acute respiratory failure is a pulmonary disorder, patients who survive their hospitalization are not limited by respiratory symptoms after discharge. Rather persistent neuromuscular weakness is the primary disorder that adversely alters their quality of life and ability to function on a daily basis. In this application the investigators plan to conduct a randomized clinical trial called the Do It Now study (Diagnosis and Treatment of Neuromuscular Weakness) to determine the effectiveness of an intensive physical therapy program for patients recovering from acute respiratory failure. This trial will establish the efficacy of the physical therapy programs that is currently performed for patients with acute respiratory failure in a non-evidence based manner across the United States.
Eligibility Criteria
Inclusion Criteria
- Acute respiratory failure requiring mechanical ventilation for at least four days.
Exclusion Criteria
- Recent myocardial infarction within the last 3 weeks, presence of signs or symptoms of unstable angina or history of unstable arrhythmias including ventricular tachycardia and atrial fibrillation (HR > 100 bpm).
- Recent history of pulmonary embolism within the last six weeks.
- History of severe aortic stenosis.
- Presence of a dissecting aortic aneurysm.
- Significant language barrier that would limit the ability to participate in the physical therapy program.
- Patients who live greater than 45 miles from the University of Colorado Hospital.
- Underlying disorder that makes it unlikely that the patient will survive 6 months.
- Severe physical or cognitive impairment that would impair their ability to exercise.
Data sourced from ClinicalTrials.gov (NCT01058421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.