Treatment of Critical Illness Polyneuromyopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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 are not limited by respiratory symptoms after discharge. Rather persistent neuromuscular weakness is the primary disorder that adversely affects their quality of life and ability to function on a daily basis. Weakness in these survivors is related to the development of critical illness polyneuromyopathy (CIPNM). Presently, there are no therapies to treat the estimated 110,000 acute respiratory failure survivors who have developed CIPNM each year. Based on the results of our national surveys of physical therapists and intensive care physicians, the utilization and types of physical therapy for patients recovering from acute respiratory failure with neuromuscular weakness varies significantly depending on the type of hospital and primary diagnosis of the patient. The investigators plan to perform a randomized clinical trial to determine the effectiveness of an intensive four week physical therapy program for patients with acute respiratory failure. This trial will determine the efficacy of the physical therapy programs that is currently performed in a non-evidence based manner for patients with acute respiratory failure across the United States. If successful, this study will pave the way for a larger multi-center clinical trial of intensive physical therapy for survivors of acute respiratory failure.

Official Title
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Randomized Trial of Intensive Physical Therapy for Patients With Acute Respiratory Failure

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Procedure: intensive physical therapy
* Procedure: control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive physical therapy<br>four week intervention of daily intensive physical therapy | Procedure: intensive physical therapy<br>* four week course of daily intensive physical therapy<br>|
| Active Comparator: control group<br> | Procedure: control group<br>* four weeks of routine physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU-free Days | Number of ICU-free days at Day 28. | Day 28 | 
| ICU Length of Stay | Median ICU length of stay through Day 28 | Total Days through Day 28 | 
| Mechanical Ventilation Duration | 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. | up to 180 days | 
| Hospital Free Days |  | Through Day 28 | 
| Hospital Length of Stay | The total number of hospital days during study participation, up to 180 days. | up to 180 days | 
| Discharged to Home | Percentage of subjects discharged to home from study hospital | Through Day 28 | 
| Institution Free Days | Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility. | At Day 90 | 
| Institution Free Days | Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility. | Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, acute respiratory failure, physical therapy, critical illness neuropathy, critical illness myopathy