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Mechanisms of the Relaxation Response in Elderly Hypertensives

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Center for Complementary and Alternative Medicine (NCCAM).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00913991
First received: June 3, 2009
Last updated: February 24, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Hypertension
Behavioral: Stress Management Training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mechanisms of the Relaxation Response in Elderly Hypertensives

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nitric Oxide and epinephrine levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913991

Contacts
Contact: Amber Fyfe-Johnson, ND 612/863-9865 amber.fyfe-johnson@allina.com

Locations
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55410
Contact: Jeffery Dusek, PhD    612-863-6105    jeffery.dusek@allina.com   
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffery Dusek, PhD Abbott Northwestern Hospital
  More Information

No publications provided

Responsible Party: Jeffery Dusek,PhD, Abbott Northwestern Hospital, Allina Health System
ClinicalTrials.gov Identifier: NCT00913991     History of Changes
Other Study ID Numbers: R21 AT003315-01
Study First Received: June 3, 2009
Last Updated: February 24, 2010
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Nitric Oxide

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014