Treatment of Critical Illness Polyneuromyopathy

Not Applicable

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Procedure: control group; Procedure: intensive physical therapy

• Registration Number: NCT01058421
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Primary Completion: 2014-05
• Study Completion: 2015-10
• Results First Submitted: 2016-07-22
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-16
• Last Update Submitted: 2017-03-16
• Results First Posted: 2017-04-27
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Acute respiratory failure requiring mechanical ventilation for at least four days.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	control group	-
Intensive physical therapy	intensive physical therapy	four week intervention of daily intensive physical therapy

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
ICU-free Days	Day 28	Number of ICU-free days at Day 28.
ICU Length of Stay	Total Days through Day 28	Median ICU length of stay through Day 28
Mechanical Ventilation Duration	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	Through Day 28
Hospital Length of Stay	up to 180 days	The total number of hospital days during study participation, up to 180 days.
Discharged to Home	Through Day 28	Percentage of subjects discharged to home from study hospital
Institution Free Days	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.

Trial Locations

Locations (5)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

St. Anthony Hospital; 🇺🇸 Lakewood, Colorado, United States

Medical Center of Aurora; 🇺🇸 Aurora, Colorado, United States

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

Rose Medical Center; 🇺🇸 Denver, Colorado, United States