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Mechanisms of the Relaxation Response in Elderly Hypertensives

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ClinicalTrials.gov Identifier: NCT00913991
Recruitment Status : Unknown
Verified February 2010 by National Center for Complementary and Integrative Health (NCCIH).
Recruitment status was:  Recruiting
First Posted : June 4, 2009
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

June 3, 2009
June 4, 2009
February 26, 2010
March 2009
June 2011   (Final data collection date for primary outcome measure)
Systolic Blood Pressure [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT00913991 on ClinicalTrials.gov Archive Site
Nitric Oxide and epinephrine levels [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
Mechanisms of the Relaxation Response in Elderly Hypertensives
Mechanisms of the Relaxation Response in Elderly Hypertensives

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Hypertension
Behavioral: Stress Management Training
Weekly 60-minute session with a trainer for 8 consecutive weeks. Daily home practice of approximately 20 minutes per day via CD.
  • Experimental: Stress Management #1
    8 weeks of individual stress management training sessions
    Intervention: Behavioral: Stress Management Training
  • Active Comparator: Stress Management #2
    8 weeks of individual stress management training sessions
    Intervention: Behavioral: Stress Management Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
90
Same as current
December 2011
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00913991
R21AT003315-01( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Jeffery Dusek,PhD, Abbott Northwestern Hospital, Allina Health System
National Center for Complementary and Integrative Health (NCCIH)
Not Provided
Principal Investigator: Jeffery Dusek, PhD Abbott Northwestern Hospital
National Center for Complementary and Integrative Health (NCCIH)
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP