Effect of Whole Body Periodic Acceleration on Airway Endothelial Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adam Wanner, University of Miami
ClinicalTrials.gov Identifier:
NCT01213706
First received: October 1, 2010
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

In the present proposal the investigators wish to assess the effect of a single session with the device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) on baseline airway blood flow (Qaw) and in Qaw variation, in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers, with the expectation that the treatment will transiently increase the Qaw, and to a greater extent in the current smokers and patients with asthma who have endothelial dysfunction.


Condition Intervention
Healthy Control
Smokers
Asthma
Device: Whole Body Periodic Acceleration (WBPA)
Device: Sham WBPA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Whole Body Periodic Acceleration on Airway Endothelial Function in Healthy Smokers, Non-smokers and Asmathics

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Airway Blood Flow Response to Albuterol [ Time Frame: Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA ] [ Designated as safety issue: No ]
    Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.


Enrollment: 45
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole Body Periodic Acceleration (WBPA)

Sham WBPA :The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.

Washout period: 1 hour. WBPA: Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.

Device: Whole Body Periodic Acceleration (WBPA)
Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
Device: Sham WBPA
The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.

Detailed Description:

Endothelial shear stress activates nitric oxide synthase (NOS), leading to endothelium-dependent vasodilation. This can be accomplished through exercise or with a device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) that is also called pGz. WBPA produces systemic vasodilation, by exerting shear stress on the vascular endothelium, activating endothelial NOS and releasing NO in animal models and human subjects. Cigarette smoking is associated with attenuated vascular relaxation responses in the systemic circulation. Patients with asthma also exhibit endothelial dysfunction in the airway. In this study the investigators wish to assess the effect of a single pGz session on baseline Qaw and delta Qaw in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers to test if this treatment will increase the vascular relaxation responses.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

15 healthy never-smokers, 15 smokers (> than 1 year smoke history) and 15 never-smokers asmathics; FEV1 > 80% (except for asmathics subjets)

Exclusion Criteria:

Women of childbearing potential who do not accepted birth control measures; pregnant and breast feeding; cardiovascular disease or use of cardiovascular drugs; respiratory infection during the 4 weeks preceding the study; use of inhaled or systemic glucocorticoids, leukotriene modifiers or theophyllines in asmathics; FEV1 < 80% on the screening day (excepted for asmathics subjets)

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01213706

Locations
United States, Florida
Pulmonary Human Research Laboratory, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Adam Wanner, MD University of Miami
  More Information

Publications:
Responsible Party: Adam Wanner, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT01213706     History of Changes
Other Study ID Numbers: 20090748
Study First Received: October 1, 2010
Results First Received: March 25, 2014
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
airway blood flow
albuterol
Whole Body Periodic Acceleration (WBPA)
Nitric Oxide
Endothelial Dysfunction

ClinicalTrials.gov processed this record on September 16, 2014