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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive physical therapy | Experimental | four week intervention of daily intensive physical therapy |
|
| control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive physical therapy | Procedure | four week course of daily intensive physical therapy |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Moss, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center of Aurora | Aurora | Colorado | 80012 | United States | ||
| University of Colorado Denver |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28732512 | Derived | 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. | |
| 26651376 | Derived |
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We have created a de-identified data set that is available to other investigators upon request.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 Month Outcomes |
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| 3 Month Outcomes |
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| 6 Month Outcomes |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard of Care Physical Therapy Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Error | score | 1 month |
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | Non-systematic Assessment | One subject had a syncopal episode during a physical therapy session. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc Moss | University of Colorado | 303-724-6079 | marc.moss@ucdenver.edu |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| control group | Procedure | four weeks of routine physical therapy |
|
| 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 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| Swedish Medical Center | Englewood | Colorado | 80113 | United States |
| St. Anthony Hospital | Lakewood | Colorado | 80228 | United States |
| 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. |
| Remained in Hospital |
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| Remained in Other Facility |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Number | participants |
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| Secondary | ICU-free Days | Number of ICU-free days at Day 28. | Posted | Median | Inter-Quartile Range | Days | Day 28 |
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| Secondary | ICU Length of Stay | Median ICU length of stay through Day 28 | Posted | Median | Inter-Quartile Range | Days | Total Days through Day 28 |
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|
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| 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. | Posted | Median | Inter-Quartile Range | Days | up to 180 days |
|
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| Secondary | Hospital Free Days | Posted | Median | Inter-Quartile Range | Days | Through Day 28 |
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| Secondary | Hospital Length of Stay | The total number of hospital days during study participation, up to 180 days. | Posted | Median | Inter-Quartile Range | Days | up to 180 days |
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| Secondary | Discharged to Home | Percentage of subjects discharged to home from study hospital | Posted | Number | percentage of participants | Through Day 28 |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Days | At Day 90 |
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|
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Days | Day 180 |
|
|
|
| 0 |
| 59 |
| 1 |
| 59 |
| EG001 | 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. | 0 | 61 | 1 | 61 |
|
| Polyarthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One subject was readmitted to study hospital for 2 day stay after initial hospital stay due to polyarthralgia that was possibly related to physical therapy interventions. |
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| D008722 | Methods |