Mechanisms of the Relaxation Response in Elderly Hypertensives
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hypertension
Started Mar 2009
Longer than P75 for phase_1 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 3, 2009
CompletedFirst Posted
Study publicly available on registry
June 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 11, 2019
February 1, 2010
2.3 years
June 3, 2009
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic Blood Pressure
8 weeks
Secondary Outcomes (1)
Nitric Oxide and epinephrine levels
8 weeks
Study Arms (2)
Stress Management #1
EXPERIMENTAL8 weeks of individual stress management training sessions
Stress Management #2
ACTIVE COMPARATOR8 weeks of individual stress management training sessions
Interventions
Weekly 60-minute session with a trainer for 8 consecutive weeks. Daily home practice of approximately 20 minutes per day via CD.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55410, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffery Dusek, PhD
Allina Health System
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
June 3, 2009
First Posted
June 4, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2011
Study Completion
December 1, 2011
Last Updated
September 11, 2019
Record last verified: 2010-02