Effect of Whole Body Periodic Acceleration on Airway Endothelial Function

NCT ID: NCT01213706

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-05-31

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.

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.

Conditions

Healthy; Smokers; Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Whole Body Periodic Acceleration (WBPA)

Intervention Type: DEVICE

Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.

Sham WBPA

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Whole Body Periodic Acceleration (WBPA)

Intervention Type: DEVICE

Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.

Sham WBPA

Intervention Type: DEVICE

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

Interventions

Whole Body Periodic Acceleration (WBPA)

Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.

Intervention Type: DEVICE

Sham WBPA

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Adam Wanner

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Wanner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Pulmonary Human Research Laboratory, University of Miami Miller School of Medicine

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15653959 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16236957 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18159115 (View on PubMed)

Other Identifiers

20090748

Identifier Type: -

Identifier Source: org_study_id