Acute Respiratory Failure
Conditions
Keywords
mechanical ventilation, acute respiratory failure, physical therapy, critical illness neuropathy, critical illness myopathy
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.
Interventions
PROCEDUREintensive physical therapy
four week course of daily intensive physical therapy
PROCEDUREcontrol group
four weeks of routine physical therapy
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay | Total Days through Day 28 | Median ICU length of stay through Day 28 |
| Mechanical Ventilation Duration | 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 | Through Day 28 | — |
| ICU-free Days | Day 28 | Number of ICU-free days at Day 28. |
| Discharged to Home | Through Day 28 | Percentage of subjects discharged to home from study hospital |
| Institution Free Days | 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. |
| Hospital Length of Stay | up to 180 days | The total number of hospital days during study participation, up to 180 days. |
Countries
United States
Participant flow
Pre-assignment details
Deceased subjects were removed from starting period subject numbers for subsequent outcome periods in each cohort. All non-deceased subjects were included in period outcomes analysis and categorized as death in subsequent period, lost to follow-up, remained in hospital or other facility.
Participants by arm
| Arm | Count |
|---|---|
| Intensive Physical Therapy Treatment Group Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28. | 59 |
| Standard of Care Physical Therapy Group Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28. | 61 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1 Month Outcomes | Death | 10 | 6 |
| 1 Month Outcomes | Lost to Follow-up | 8 | 7 |
| 1 Month Outcomes | Remained in Hospital | 5 | 12 |
| 1 Month Outcomes | Remained in Other Facility | 16 | 17 |
| 3 Month Outcomes | Death | 3 | 5 |
| 3 Month Outcomes | Lost to Follow-up | 12 | 11 |
| 3 Month Outcomes | Remained in Hospital | 0 | 2 |
| 3 Month Outcomes | Remained in Other Facility | 5 | 8 |
| 6 Month Outcomes | Death | 2 | 2 |
| 6 Month Outcomes | Lost to Follow-up | 16 | 21 |
| 6 Month Outcomes | Remained in Other Facility | 1 | 3 |
Baseline characteristics
| Characteristic | Intensive Physical Therapy Treatment Group | Standard of Care Physical Therapy Group | Total |
|---|---|---|---|
| Age, Continuous | 56 years | 49 years | 53 years |
| Sex/Gender, Customized Female | 24 participants | 26 participants | 50 participants |
| Sex/Gender, Customized Male | 35 participants | 35 participants | 70 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 59 | 1 / 61 |
| serious Total, serious adverse events | 0 / 59 | 0 / 61 |
Outcome results
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
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.
Time frame: 1 month
Population: 41 of 59 subjects were analyzed in the Intensive Treatment Group (20 completed outcomes testing + 5 remained in hospital + 16 remained in another facility = 41 subjects). 48 of 61 Standard of Care Group subjects were analyzed (19 completed outcomes testing + 12 remained in hospital + 17 remained in another facility = 48).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intensive Physical Therapy Treatment Group | 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 | 19.0 score | Standard Error 3.7 |
| Standard of Care Physical Therapy Group | 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 | 20.9 score | Standard Error 4.1 |
Secondary
Discharged to Home
Percentage of subjects discharged to home from study hospital
Time frame: Through Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Physical Therapy Treatment Group | Discharged to Home | 51 percentage of participants |
| Standard of Care Physical Therapy Group | Discharged to Home | 49 percentage of participants |
Secondary
Hospital Free Days
Time frame: Through Day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Physical Therapy Treatment Group | Hospital Free Days | 7 Days |
| Standard of Care Physical Therapy Group | Hospital Free Days | 7 Days |
Secondary
Hospital Length of Stay
The total number of hospital days during study participation, up to 180 days.
Time frame: up to 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Physical Therapy Treatment Group | Hospital Length of Stay | 21 Days |
| Standard of Care Physical Therapy Group | Hospital Length of Stay | 21 Days |
Secondary
ICU-free Days
Number of ICU-free days at Day 28.
Time frame: Day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Physical Therapy Treatment Group | ICU-free Days | 13 Days |
| Standard of Care Physical Therapy Group | ICU-free Days | 11 Days |
Secondary
ICU Length of Stay
Median ICU length of stay through Day 28
Time frame: Total Days through Day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Physical Therapy Treatment Group | ICU Length of Stay | 15 Days |
| Standard of Care Physical Therapy Group | ICU Length of Stay | 16 Days |
Secondary
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.
Time frame: At Day 90
Population: Deceased subjects were not included in subsequent Period beginning subject started totals.~59 (Subjects started Period 1) minus 10 (deceased subjects during Period 1) = 49 started Period 2.~61 (Subjects started Period 1) minus 6 (deceased subjects during Period 1) = 55 started Period 2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Physical Therapy Treatment Group | Institution Free Days | 61 Days |
| Standard of Care Physical Therapy Group | Institution Free Days | 56 Days |
Secondary
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.
Time frame: Day 180
Population: Deceased subjects were not included in subsequent Period beginning subject started totals.~55 (subjects started Period 1) minus 13 (deceased subjects in Periods 1 \& 2) = 46 started Period 3.~61 (subjects started Period 1) minus 11 (deceased subjects in Periods 1 \& 2) = 50 started Period 3.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Physical Therapy Treatment Group | Institution Free Days | 151 Days |
| Standard of Care Physical Therapy Group | Institution Free Days | 146 Days |
Secondary
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.
Time frame: up to 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intensive Physical Therapy Treatment Group | Mechanical Ventilation Duration | 10 Days |
| Standard of Care Physical Therapy Group | Mechanical Ventilation Duration | 10 Days |