Treatment of Critical Illness Polyneuromyopathy

NCT01058421 | Completed Results DMC

• 1 other identifier: 09-0214
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Respiratory Failure

Keywords

mechanical ventilation; acute respiratory failure; physical therapy; critical illness neuropathy; critical illness myopathy

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  1 month

Secondary Outcomes (8)

• ICU-free Days

  Day 28

• ICU Length of Stay

  Total Days through Day 28

• Mechanical Ventilation Duration

  up to 180 days

• Hospital Free Days

  Through Day 28

• Hospital Length of Stay

  up to 180 days

Study Arms (2)

Intensive physical therapy

EXPERIMENTAL

four week intervention of daily intensive physical therapy

Procedure: intensive physical therapy

control group

ACTIVE COMPARATOR

Procedure: control group

Interventions

intensive physical therapy PROCEDURE

four week course of daily intensive physical therapy

Intensive physical therapy

control group PROCEDURE

four weeks of routine physical therapy

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute respiratory failure requiring mechanical ventilation for at least four days.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (5)

Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

St. Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Related Publications (2)

• 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.

  PMID: 28732512 DERIVED

• 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.

  PMID: 26651376 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Marc Moss
• Organization: University of Colorado

marc.moss@ucdenver.edu

303-724-6079

Study Officials

• Marc Moss, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: September 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2015
• Last Updated: April 27, 2017
• Results First Posted: April 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (5)