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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03195127
Other study ID # HP-00047963
Secondary ID R03AG045100
Status Completed
Phase N/A
First received
Last updated
Start date June 28, 2011
Est. completion date February 1, 2017

Study information

Verified date May 2023
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
United States U of Maryland, Baltimore, Professional Schools IRB Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
University of Maryland, Baltimore National Institute on Aging (NIA), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Assessment: Handgrip Handgrip strength will be reported in kilograms Upon completing of study, up to 56 days
Primary Functional Assessment: Short Physical Performance Battery (SPPB) Short Physical Performance Battery will be reported as a score from 0 to 12 from with lower scores indicating a worse outcome Upon Completion of study, up to 56 days
Primary Functional Assessment: 4 Meter Gait Speed 4 meter gait speed will be reported in meters per second Upon completion of study, up to 56 days
Primary Functional Assessment: 6 Minute Walk Distance 6 minute walk distance will be reported in feet Upon completion of study, up to 56 days
Secondary Percent of Patients Weaned From Mechanical Ventilation Proportion of patients weaned from mechanical ventilation expressed in percent of total in group Upon completion of study, up to 56 days
Secondary Percent of Patients Discharged Home Proportion of patients discharged home as a percentage of all patients in group Upon completion of study, up to 56 days
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