Treatment of Critical Illness Polyneuromyopathy

Acute Respiratory Failure Clinical Trial

— Do-It-Now  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01058421
• Other study ID #: 09-0214
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 26, 2010
• Last updated: January 8, 2016
• Start date: September 2009
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Critical Illness
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• intensive physical therapy
four week course of daily intensive physical therapy
• control group
four weeks of routine physical therapy

Locations

Country	Name	City	State
United States	Medical Center of Aurora	Aurora	Colorado
United States	University of Colorado Denver	Aurora	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	Swedish Medical Center	Englewood	Colorado
United States	St. Anthony Hospital	Lakewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).		3 and 6 months	No