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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Procedure: intensive physical therapy; Procedure: control group

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Aurora, Colorado, United States, 80012
      • Medical Center of Aurora
    • Denver, Colorado, United States, 80220
      • Rose Medical Center
    • Englewood, Colorado, United States, 80113
      • Swedish Medical Center
    • Lakewood, Colorado, United States, 80228
      • St. Anthony Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: control group	Procedure: control group; four weeks of routine physical therapy
EXPERIMENTAL: Intensive physical therapy; four week intervention of daily intensive physical therapy	Procedure: intensive physical therapy; four week course of daily intensive physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU-free Days	Number of ICU-free days at Day 28.	Day 28
ICU Length of Stay	Median ICU length of stay through Day 28	Total Days through Day 28
Mechanical Ventilation Duration	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.	up to 180 days
Hospital Free Days		Through Day 28
Hospital Length of Stay	The total number of hospital days during study participation, up to 180 days.	up to 180 days
Discharged to Home	Percentage of subjects discharged to home from study hospital	Through Day 28
Institution Free Days	Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility.	At Day 90
Institution Free Days	Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility.	Day 180

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Marc Moss, M.D., University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 27, 2010
• First Posted (ESTIMATE): January 28, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: mechanical ventilation; physical therapy; acute respiratory failure; critical illness myopathy; critical illness neuropathy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Respiratory Insufficiency; Critical Illness; Respiratory Distress Syndrome
• Other Study ID Numbers: 09-0214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We have created a de-identified data set that is available to other investigators upon request.