Effect of Whole Body Periodic Acceleration on Airway Endothelial Function

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT01213706
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy; Smokers; Asthma	Device: Whole Body Periodic Acceleration (WBPA); Device: Sham WBPA	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Whole Body Periodic Acceleration on Airway Endothelial Function in Healthy Smokers, Non-smokers and Asthmatics
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Whole Body Periodic Acceleration (WBPA) 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.	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.
Experimental: Sham WBPA 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.	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.

Outcome Measures

Primary Outcome Measures

1. Airway Blood Flow Response to Albuterol [Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA]

   Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Sackner MA, Gummels E, Adams JA. Nitric oxide is released into circulation with whole-body, periodic acceleration. Chest. 2005 Jan;127(1):30-9.

• Responsible Party: Adam Wanner, Professor of Medicine, University of Miami
• ClinicalTrials.gov Identifier: NCT01213706
• Other Study ID Numbers: 20090748
• First Posted: Oct 4, 2010
• Last Update Posted: Aug 10, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Adam Wanner, Professor of Medicine, University of Miami: airway blood flow; albuterol; Whole Body Periodic Acceleration (WBPA); Nitric Oxide; Endothelial Dysfunction

Study Results

Participant Flow

Arm/Group Title	SHAM WBPA Then WBPA
Arm/Group Description
Period Title: Sham WBPA
STARTED	45
COMPLETED	45
NOT COMPLETED	0
Period Title: Sham WBPA
STARTED	45
COMPLETED	45
NOT COMPLETED	0
Period Title: Sham WBPA
STARTED	45
COMPLETED	45
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Whole Body Periodic Acceleration (WBPA)
Arm/Group Description	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.
Overall Participants	45
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	45 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	18 40%
Male	27 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 8.9%
White	41 91.1%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	45 100%

Outcome Measures

1. Primary Outcome

Title	Airway Blood Flow Response to Albuterol
Description	Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.
Time Frame	Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA

Outcome Measure Data

Analysis Population Description

controls n =15, smokers N=15 , asthma N=15

Arm/Group Title	WBPA	Sham WBPA
Arm/Group Description	Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.	Subjects will be resting on the platform without any WBPA.
Measure Participants	45	45
Smokers n=15,15	2.85 (2.33)	-1.43 (2.8)
Controls N=15, 15	17.93 (2.08)	4.03 (0.8)
Asthma N=15,15	1.96 (2.06)	1.65 (0.8)

Adverse Events

Arm/Group Title	Whole Body Periodic Acceleration (WBPA)		Sham WBPA
Arm/Group Description	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.		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.
All Cause Mortality
	Whole Body Periodic Acceleration (WBPA)		Sham WBPA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Whole Body Periodic Acceleration (WBPA)		Sham WBPA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Whole Body Periodic Acceleration (WBPA)		Sham WBPA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.