intensive physical therapy
Procedurefour week course of daily intensive physical therapy
NCT Number: NCT01058421
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Medical Center of Aurora, Aurora, Colorado, 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
four week course of daily intensive physical therapy
four weeks of routine physical therapy
Time frame: 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.
Time frame: Day 28
Number of ICU-free days at Day 28.
Time frame: Total Days through Day 28
Median ICU length of stay through Day 28
Time frame: 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.
Time frame: Through Day 28
Time frame: up to 180 days
The total number of hospital days during study participation, up to 180 days.
Time frame: Through Day 28
Percentage of subjects discharged to home from study hospital
Time frame: 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.
Time frame: Day 180
Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility.
University of Colorado, Denver
Other
Randomized Trial of Intensive Physical Therapy for Patients With Acute Respiratory Failure
Acronym: Do-It-Now
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06876168
Acute Respiratory Failure, Infections
Lexington, Kentucky, United States
View Trial DetailsNCT02723565
Acute Respiratory Failure, Pathologic Processes
Toronto, Ontario, Canada
View Trial DetailsNCT07366541
Acute Respiratory Failure, Electrical Impedance Tomography (EIT)
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05423301
Acute Respiratory Failure
Pessac, France
View Trial Details