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
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
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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
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 Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013