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Mechanisms of the Relaxation Response in Elderly Hypertensives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00913991
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dusek, Jeffery, National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Stress Management Training Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mechanisms of the Relaxation Response in Elderly Hypertensives
Study Start Date : March 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stress Management #1
8 weeks of individual stress management training sessions
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.

Active Comparator: Stress Management #2
8 weeks of individual stress management training sessions
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.




Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Nitric Oxide and epinephrine levels [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913991


Locations
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United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55410
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Jeffery Dusek, PhD Allina Health System
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Responsible Party: Dusek, Jeffery, Research Director, National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT00913991    
Other Study ID Numbers: R21AT003315-01 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: February 2010
Keywords provided by Dusek, Jeffery, National Center for Complementary and Integrative Health (NCCIH):
Nitric Oxide
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases