Mechanisms of the Relaxation Response in Elderly Hypertensives

Study Overview
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Brief Summary
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Systolic Hypertension is a disorder which is characterized by significant elevations in systolic blood pressure in association with normal diastolic blood pressure. Typically, this develops in individuals >50 years of age and is associated with an increased risk of stroke and myocardial infarction. While there are many effective therapies for essential/diastolic hypertension, the treatment of systolic hypertension is complicated by side effects from traditional therapies. This limits therapeutic options and has resulted in a number of at-risk individuals being left untreated. We are conducting a randomized, controlled trial (n=90) to compare the effects of two different stress management training on blood pressure. The primary outcome is change in systolic blood pressure and pulse pressure. Secondary outcomes are changes in nitric oxide, stress hormones and psychological well-being. Additional analyses will be conducted to assess for other confounding effects on BP and PP.

Official Title
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Mechanisms of the Relaxation Response in Elderly Hypertensives

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Stress Management Training
* Behavioral: Stress Management Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female; stage I SH (140-159 mm Hg SBP and < 90 mm Hg DBP), > 55 years of age; taking at least 1 anti-hypertensive medication at a stable dose for 1 month preceding the screening visit; understanding of English; normal hearing; and able to provide informed consent. Exclusion Criteria: Presence of current neurological, psychiatric, medical or musculoskeletal disorder; current asthma; severe seasonal allergies resulting in screening NO values > 60 ppb; current smoking; experience with yoga, meditation, guided imagery or other techniques that evoke the RR; hematocrit below 32; glucose lower than 50 or higher than 200; a creatinine greater than 1.3, Mini-Mental Status Exam score less than 26 or clinical depression based on a score of greater than 15 on the CES-D and Health Counselor's clinical evaluation. Subjects can not take the following medications: beta-agonist bronchodilators, systemic corticosteroids, anti-convulsants, immunosuppressive or cytotoxic therapy (currently or within the last 12 months), anabolic steroids, anti-depressants (not including SSRIs), anti-psychotics, chronic sypathomimetic medications, and dicyclomine.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Management #1<br>8 weeks of individual stress management training sessions | Behavioral: Stress Management Training<br>* Weekly 60-minute session with a trainer for 8 consecutive weeks. Daily home practice of approximately 20 minutes per day via CD.<br>|
| Active Comparator: Stress Management #2<br>8 weeks of individual stress management training sessions | Behavioral: Stress Management Training<br>* Weekly 60-minute session with a trainer for 8 consecutive weeks. Daily home practice of approximately 20 minutes per day via CD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitric Oxide and epinephrine levels |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitric Oxide