Stress Reduction & CVD Morbidity and Mortality in Blacks
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypertension
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
meditation
relaxation
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Inner-city Blacks with mild hypertension
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000537
First Posted
October 27, 1999
Last Updated
July 23, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000537
Brief Title
Stress Reduction & CVD Morbidity and Mortality in Blacks
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 1992 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
meditation
Intervention Type
Behavioral
Intervention Name(s)
relaxation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inner-city Blacks with mild hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Schneider
Organizational Affiliation
Maharishi International University
12. IPD Sharing Statement
Citations:
PubMed Identifier
7591024
Citation
Schneider RH, Staggers F, Alxander CN, Sheppard W, Rainforth M, Kondwani K, Smith S, King CG. A randomised controlled trial of stress reduction for hypertension in older African Americans. Hypertension. 1995 Nov;26(5):820-7. doi: 10.1161/01.hyp.26.5.820.
Results Reference
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PubMed Identifier
8707387
Citation
Alexander CN, Schneider RH, Staggers F, Sheppard W, Clayborne BM, Rainforth M, Salerno J, Kondwani K, Smith S, Walton KG, Egan B. Trial of stress reduction for hypertension in older African Americans. II. Sex and risk subgroup analysis. Hypertension. 1996 Aug;28(2):228-37. doi: 10.1161/01.hyp.28.2.228.
Results Reference
background
PubMed Identifier
9220696
Citation
Barnes V, Schneider R, Alexander C, Staggers F. Stress, stress reduction, and hypertension in African Americans: an updated review. J Natl Med Assoc. 1997 Jul;89(7):464-76.
Results Reference
background
PubMed Identifier
15691622
Citation
Schneider RH, Alexander CN, Staggers F, Orme-Johnson DW, Rainforth M, Salerno JW, Sheppard W, Castillo-Richmond A, Barnes VA, Nidich SI. A randomized controlled trial of stress reduction in African Americans treated for hypertension for over one year. Am J Hypertens. 2005 Jan;18(1):88-98. doi: 10.1016/j.amjhyper.2004.08.027.
Results Reference
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Stress Reduction & CVD Morbidity and Mortality in Blacks
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