Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients
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|ClinicalTrials.gov Identifier: NCT03195127|
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
As the general population ages and technology advances, many who suffer from catastrophic critical illness (i.e. septic shock, respiratory failure, Acute Respiratory Disease Syndrome) survive only to find themselves severely physically debilitated and compromised from a pulmonary standpoint, requiring assistance from a mechanical ventilator in order to breath. Oftentimes, these patients require a long course of physical rehabilitation and ventilator support. These patients frequently remain ventilator dependent for greater than 3 weeks, and are thus referred to as requiring prolonged mechanical ventilation (PMV).
Older patients are at significantly higher risk for requiring PMV for reasons that are not entirely clear, but which may include physical deconditioning, impaired cardiopulmonary physiology, and cognitive or behavioral disturbances.
The purpose of this study is two fold: 1. to characterize the functional phenotype of ventilator dependent, and recently ventilated patients with respect to general strength, endurance, balance, and pulmonary functioning and body composition. 2. To pilot test a rehabilitation protocol that targets improving this populations disabilities through exercises focused on improving strength, endurance, balance, and pulmonary functioning.
|Condition or disease||Intervention/treatment||Phase|
|Respiration, Artificial Critical Illness Chronic Disease Exercise Therapy Rehabilitation Physical Therapy Modalities||Other: multimodal physical therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||Up to 75 patients will be screened with a goal of enrolling 40 for participate in the intervention trial (20 in the multimodal treatment arm and 20 in a group receiving usual care).|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients|
|Actual Study Start Date :||June 28, 2011|
|Actual Primary Completion Date :||July 31, 2015|
|Actual Study Completion Date :||February 1, 2017|
Experimental: multimodal physical therapy
Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills.
Other: multimodal physical therapy
Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist
No Intervention: Usual care
Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
- Functional Assessment: Handgrip [ Time Frame: Upon completing of study, up to 56 days ]Handgrip strength will be reported in kilograms
- Functional Assessment: Short Physical Performance battery (SPPB) [ Time Frame: Upon Completion of study, up to 56 days ]Short Physical Performance Battery will be reported as a score from 0 (worst to 12 (highest)
- Functional Assessment: 4 meter gait speed [ Time Frame: Upon completion of study, up to 56 days ]4 meter gait speed will be reported in meters per second
- Functional Assessment: 6 minute walk distance [ Time Frame: Upon completion of study, up to 56 days ]6 minute walk distance will be reported in feet
- Percent of patients weaned from mechanical ventilation [ Time Frame: Upon completion of study, up to 56 days ]Percent of patients weaned from mechanical ventilation
- Percent of patients discharged home [ Time Frame: Upon completion of study, up to 56 days ]Percent of patients discharged home
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195127
|United States, Maryland|
|U of Maryland, Baltimore, Professional Schools IRB|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Avelino C Verceles, MD,MS||University of Maryland, Baltimore|