Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Body Periodic Acceleration (WBPA) | Experimental | All subjects will be performing this procedure. 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. |
|
| Sham WBPA | Experimental | Sham WBPA : All subjects will be performing this procedure before the WBPA. The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Body Periodic Acceleration (WBPA) | Device | Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Airway Blood Flow Response to Albuterol | Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation. | Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA |
Not provided
Not provided
Inclusion Criteria:
15 healthy never-smokers, 15 smokers (> than 1 year smoke history) and 15 never-smokers asthmatics; FEV1 > 80% (except for asthmatics 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 asthmatics; FEV1 < 80% on the screening day (excepted for asthmatics subjets)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam Wanner, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Human Research Laboratory, University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15653959 | Background | Sackner MA, Gummels E, Adams JA. Nitric oxide is released into circulation with whole-body, periodic acceleration. Chest. 2005 Jan;127(1):30-9. doi: 10.1378/chest.127.1.30. | |
| 16236957 | Background | Sackner MA, Gummels E, Adams JA. Effect of moderate-intensity exercise, whole-body periodic acceleration, and passive cycling on nitric oxide release into circulation. Chest. 2005 Oct;128(4):2794-803. doi: 10.1378/chest.128.4.2794. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SHAM WBPA Then WBPA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sham WBPA |
| |||||||||||||
| Washout (1 Hour) |
| |||||||||||||
| WBPA |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Whole Body Periodic Acceleration (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. Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Airway Blood Flow Response to Albuterol | Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation. | controls n =15, smokers N=15 , asthma N=15 | Posted | Mean | Standard Error | μl/min/ml | Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Whole Body Periodic Acceleration (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. Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Wanner, MD | University of Miami | (305) 243-2568 | awanner@med.miami.edu |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham WBPA | Device | The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge. |
|
| 18159115 | Background | Matsumoto T, Fujita M, Tarutani Y, Yamane T, Takashima H, Nakae I, Horie M. Whole-body periodic acceleration enhances brachial endothelial function. Circ J. 2008 Jan;72(1):139-43. doi: 10.1253/circj.72.139. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Sham WBPA | The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge. Sham WBPA: The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge. | 0 | 45 | 0 | 45 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |