Treatment of Critical Illness Polyneuromyopathy (Do It Now)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01058421
First received: January 26, 2010
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 we 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.


Condition Intervention Phase
Acute Respiratory Failure
Procedure: intensive physical therapy
Procedure: control group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Intensive Physical Therapy for Patients With Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Two minute walk test (2 MWT), Timed Up and Go Test (TUG), and Health Related Quality of Life Measurements:Medical Outcomes Study 36-Item Short Form Health Survey, Standard Form (SF-36). [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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. We 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, our study will pave the way for a larger multi-center clinical trial of intensive physical therapy for survivors of acute respiratory failure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058421

Contacts
Contact: Marc Moss, M.D. 303-724-6079 marc.moss@ucdenver.edu
Contact: Meredith Mealer, R.N. 303-724-6080 meredith.mealer@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Marc Moss, M.D.    303-724-6079    marc.moss@ucdenver.edu   
Principal Investigator: Marc Moss, M.D.         
Medical Center of Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Marc Moss, MD    303-724-6079    marc.moss@ucdenver.edu   
Principal Investigator: Marc Moss, MD         
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Marc Moss, MD    303-724-6079    marc.moss@ucdenver.edu   
Principal Investigator: Marc Moss, MD         
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Marc Moss, MD    303-724-6079    marc.moss@ucdenver.edu   
Principal Investigator: Marc Moss, MD         
St. Anthony Hospital Recruiting
Lakewood, Colorado, United States, 80228
Contact: Marc Moss, MD    303-724-6079    marc.moss@ucdenver.edu   
Principal Investigator: Marc Moss, MD         
Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01058421     History of Changes
Other Study ID Numbers: 09-0214
Study First Received: January 26, 2010
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
mechanical ventilation
acute respiratory failure
physical therapy
critical illness neuropathy
critical illness myopathy

Additional relevant MeSH terms:
Critical Illness
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on August 28, 2014