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Stress Reduction & CVD Morbidity and Mortality in Blacks
This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000537
  Purpose

To compare the effects of two stress reduction techniques, Transcendental Meditation (TM) and Progressive Muscle Relaxation (PMR), on the control of mild hypertension in elderly Blacks with hypertension.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Behavioral: meditation
Behavioral: relaxation
Phase II

MedlinePlus related topics: Heart Diseases High Blood Pressure Vascular Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1992
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Life expectancy for Black Americans is about 10 percent less than for whites. The leading cause of excessive mortality in older Blacks is cardiovascular disease which may be largely due to disproportionately high rates of hypertension in older Blacks. Conventional antihypertensive drug therapies are frequently associated with adverse effects on quality-of-life (QL) and low compliance rates, especially in elderly minority populations.

The present study is an extension of a pilot study on a comparable sample of 80 Black elderly. The previous study, which was the first of its kind, yielded results which indicated that both TM and PMR produced moderate reductions in systolic and diastolic blood pressure, with TM producing the most significant improvements in blood pressure and in quality-of-life. Dr. Schneider hypothesized from this and related evidence that TM should prove to be an effective therapeutic adjunct to regular pharmacotherapy for mild hypertension in elderly Blacks, and should prove even more effective in fostering compliance and in improving overall quality-of-life without any of the unpleasant side effects of anti-hypertensive medications.

DESIGN NARRATIVE:

Randomized. Over an 18-month period, 213 people were screened for inclusion in the study. Of these, 127 with initial diastolic blood pressure of 90 to 109 mm Hg, systolic blood pressure of 189 mm Hg or less, and final baseline blood pressure of 179/104 or less mm Hg were randomized to treatment. Of the 127 participants, 16 did not complete follow-up blood pressure measurements. Thus, 111 subjects completed the study. All subjects were pretested over a four session baseline period on clinic blood pressure, ambulatory blood pressure, cardiovascular and emotional reactivity, and quality-of-life measures. Subjects were then randomly assigned, 36 to TM, 37 to PMR, and 38 to lifestyle modification education control and followed monthly with major post-tests at three months and eighteen months on these variables. The primary outcome variables were changes in clinic systolic and diastolic blood pressure values measured blindly. The secondary outcomes were changes in self-monitored home blood pressure and compliance.

The study was extended through July, 2007 for an additional 5 years of followup of the cohort.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inner-city Blacks with mild hypertension

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000537

Sponsors and Collaborators
Investigators
Investigator: Robert Schneider Maharishi International University
  More Information

Publications:
Study ID Numbers: 80
Study First Received: October 27, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00000537  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Heart Diseases
Vascular Diseases
Stress
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009