Treatment of Critical Illness Polyneuromyopathy

NCT ID: NCT01058421

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-10-31

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.

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive physical therapy

four week intervention of daily intensive physical therapy

Group Type: EXPERIMENTAL

intensive physical therapy

Intervention Type: PROCEDURE

four week course of daily intensive physical therapy

control group

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: PROCEDURE

four weeks of routine physical therapy

Interventions

intensive physical therapy

four week course of daily intensive physical therapy

Intervention Type: PROCEDURE

control group

four weeks of routine physical therapy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Moss, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28732512 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26651376 (View on PubMed)

Other Identifiers

09-0214

Identifier Type: -

Identifier Source: org_study_id