Clinical trial NCT01058421: Treatment of Critical Illness Polyneuromyopathy
Official title: Randomized Trial of Intensive Physical Therapy for Patients With Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: mechanical ventilation
acute respiratory failure
physical therapy
critical illness neuropathy
critical illness myopathy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 1 month
Secondary outcomes:
measure: ICU-free Days
timeFrame: Day 28
measure: ICU Length of Stay
timeFrame: Total Days through Day 28
measure: Mechanical Ventilation Duration
timeFrame: up to 180 days
measure: Hospital Free Days
timeFrame: Through Day 28
measure: Hospital Length of Stay
timeFrame: up to 180 days
measure: Discharged to Home
timeFrame: Through Day 28
measure: Institution Free Days
timeFrame: At Day 90
measure: Institution Free Days
timeFrame: Day 180
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Medical Center of Aurora
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Denver
country: United States
facility: Rose Medical Center
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Lakewood
country: United States
facility: St. Anthony Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Marc Moss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neumeier A, Nordon-Craft A, Malone D, Schenkman M, Clark B, Moss M. Prolonged acute care and post-acute care admission and recovery of physical function in survivors of acute respiratory failure: a secondary analysis of a randomized controlled trial. Crit Care. 2017 Jul 21;21(1):190. doi: 10.1186/s13054-017-1791-1.
citation: Moss M, Nordon-Craft A, Malone D, Van Pelt D, Frankel SK, Warner ML, Kriekels W, McNulty M, Fairclough DL, Schenkman M. A Randomized Trial of an Intensive Physical Therapy Program for Patients with Acute Respiratory Failure. Am J Respir Crit Care Med. 2016 May 15;193(10):1101-10. doi: 10.1164/rccm.201505-1039OC.