This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Treatment of Critical Illness Polyneuromyopathy (Do-It-Now)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01058421
First received: January 26, 2010
Last updated: March 16, 2017
Last verified: March 2017
  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 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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ]
    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:
  • ICU-free Days [ Time Frame: Day 28 ]
    Number of ICU-free days at Day 28.

  • ICU Length of Stay [ Time Frame: Total Days through Day 28 ]
    Median ICU length of stay through Day 28

  • Mechanical Ventilation Duration [ Time Frame: 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 [ Time Frame: Through Day 28 ]
  • Hospital Length of Stay [ Time Frame: up to 180 days ]
    The total number of hospital days during study participation, up to 180 days.

  • Discharged to Home [ Time Frame: Through Day 28 ]
    Percentage of subjects discharged to home from study hospital

  • Institution Free Days [ Time Frame: At Day 90 ]
    Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility.

  • Institution Free Days [ Time Frame: 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.


Enrollment: 120
Study Start Date: September 2009
Study Completion Date: October 2015
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. 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Colorado
Medical Center of Aurora
Aurora, Colorado, United States, 80012
University of Colorado Denver
Aurora, Colorado, United States, 80045
Rose Medical Center
Denver, Colorado, United States, 80220
Swedish Medical Center
Englewood, Colorado, United States, 80113
St. Anthony Hospital
Lakewood, Colorado, United States, 80228
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Marc Moss, M.D. University of Colorado, Denver
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: July 22, 2016
Last Updated: March 16, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: We have created a de-identified data set that is available to other investigators upon request.

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

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

ClinicalTrials.gov processed this record on June 23, 2017