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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inner-city Blacks with mild hypertension

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    July 23, 2008
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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
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    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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