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Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195127
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
VA Office of Research and Development
Information provided by (Responsible Party):
Avelino Verceles, University of Maryland, College Park

Brief 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.


Condition or disease Intervention/treatment Phase
Respiration, Artificial Critical Illness Chronic Disease Exercise Therapy Rehabilitation Physical Therapy Modalities Other: multimodal physical therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Functional Assessment: Handgrip [ Time Frame: Upon completing of study, up to 56 days ]
    Handgrip strength will be reported in kilograms

  2. 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)

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Percent of patients weaned from mechanical ventilation [ Time Frame: Upon completion of study, up to 56 days ]
    Percent of patients weaned from mechanical ventilation

  2. Percent of patients discharged home [ Time Frame: Upon completion of study, up to 56 days ]
    Percent of patients discharged home



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20 or greater
  • Received prolonged mechanical ventilation for >= 14 days during their last acute hospitalization
  • Has received mechanical ventilation within the past 14 days for at least 6 hours in a 24 hour period
  • Tracheostomy in place
  • Subject is able to follow commands, and can give written or witnessed verbal consent in English
  • Subject is eligible for physical rehabilitation
  • All four limbs intact and mobile

Exclusion Criteria:

  • Acute superimposed cardiopulmonary disease (ie.pulmonary edema, Stage IV congestive heart failure, COPD exacerbation, asthma attack, untreated infections, other)
  • Severe functional impairment or physical impairment to rehabilitation
  • Dementia, cognitive impairment (see attached description outlining cognitive impairment under additional documents)

Information from the National Library of Medicine

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


Locations
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United States, Maryland
U of Maryland, Baltimore, Professional Schools IRB
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, College Park
National Institute on Aging (NIA)
VA Office of Research and Development
Investigators
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Principal Investigator: Avelino C Verceles, MD,MS University of Maryland, Baltimore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Avelino Verceles, Associate Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03195127    
Other Study ID Numbers: HP-00047963
R03AG045100 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avelino Verceles, University of Maryland, College Park:
Physical Therapy Modalities
Rehabilitation
Exercise Therapy
Critical Illness
Respiration, Artificial
Chronic Disease
Additional relevant MeSH terms:
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Critical Illness
Chronic Disease
Disease Attributes
Pathologic Processes