Relaxation Response Training to Treat Hypertension

Study Overview
=================
Brief Summary
-----------------
Interventions such as Relaxation Response appear to have widespread effects on physiology. Endothelial function, changes in genomic expression, several biomarkers have been associated with chronic stress and cardiovascular dysfunction, and there is some suggestion that elicitation of the Relaxation Response may lead to improvement in-or normalization of-these factors. By studying the impact of the Relaxation Response on endothelial function, genomic expression and biomarkers among subjects with hypertension, it may be possible to better understand the biologic underpinnings of Relaxation Response-type interventions. Furthermore, with a greater understanding of the physiologic mechanisms by which the Relaxation Response works, it may be possible to better target other symptoms and conditions that can be effectively treated by such an intervention.

Official Title
-----------------
Relaxation Response Training to Treat Hypertension: Effects on Blood Pressure, Biomarkers, and Endothelial Function

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Relaxation Response
* Behavioral: Relaxation Response


Participation Criteria
=================
Eligibility Criteria
-----------------
General Inclusion Criteria: Healthy men and women Hypertension (stage 1) 18-70 years old General Exclusion Criteria No asthma or nasal allergies Non-smokers If on anti-hypertensive medication willing to discontinue Cannot currently practice Tai Chi, meditation, or yoga regularly Current use of the following medications: phosphodiesterase type 5 inhibitors, long-acting nitrates, systemic corticosteroids, anti-inflammatories, immunosuppressive or cytotoxic therapies (currently or within the last 12 months), anabolic steroids, and antidepressants.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: This is a single arm study<br>Relaxation Response training will be given to all participants | Behavioral: Relaxation Response<br>* The Relaxation Response is a type of relaxation. The goal of the Relaxation Response is to consciously elicit a reaction opposite in direction to the stress response.<br>* Other names: Meditation;Behavioral: Relaxation Response<br>* Relaxation Response is a type of relaxation. This is a technique that elicits a state that is opposite to the stress response.<br>* Other names: Meditation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Function |  | Eight weeks of Relaxation Response Training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | Eight Weeks of Relaxation Response Training | 
| Genomic Expression |  | Eight Weeks of Relaxation Response Training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage 1 hypertension