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Stress Reduction in the Prevention of Left Ventricular Hypertrophy

Primary Purpose

Left Ventricular Hypertrophy, High Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
meditation
Health education control
Sponsored by
Maharishi International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Hypertrophy focused on measuring left ventricular mass, meditation, stress reduction

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: self-identified African-American men and women ages, 20-75 years old, with either prehypertension (systolic blood pressure (SBP) of 120-139 mm Hg and/or diastolic blood pressure (DBP) of 80-89 mm Hg), Stage-1 hypertension (SBP of 140-159 mm Hg and/or DBP of 90-99 mm Hg) or Stage-2 hypertension (SBP of 160-179 and/or DBP of 100-109 mm of Hg), with or without antihypertensive medications -

Exclusion Criteria: Patients with a history of stroke, transient cerebral ischemic attack, congestive heart failure, myocardial infarction, angina pectoris or with significant ECG abnormalities, major psychiatric or behavioral disorder such as alcoholism (> 28 drinks per week)

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Transcendental Meditation

    Health Education

    Arm Description

    The Transcendental Meditation (TM) technique is described as a simple, natural technique that is practiced twice a day for 20 minutes while sitting comfortably with eyes closed. There are no required changes in lifestyle, beliefs or philosophy. Instruction in the TM technique involves a seven-step course over five sessions (90-minute meetings).

    The health education (HE) intervention provided behavioral instructions for CVD risk factor prevention . This group received written materials, structured presentations, didactic instructions and group support for modifying the major cardiovascular risk factors including salt restriction, weight reduction, aerobic exercise, alcohol and smoking cessation.

    Outcomes

    Primary Outcome Measures

    left ventricular mass (LVM)
    The primary outcome was change in LVMI. LVM was measured by M-mode echocardiography and indexed by body surface area to generate LVMI. [18] Measurements were obtained at the end-diastole. Interventricular septal thickness, posterior wall thickness, and left ventricle internal dimension were measured.

    Secondary Outcome Measures

    blood pressure
    systolic and diastolic blood pressure
    anger expression
    Speilberger Anger expression scale
    perceived stress
    Perceived Stress Scale, a 5-item subset of the California Self-Evaluation Scale to measure self-esteem, and a personal efficacy scale

    Full Information

    First Posted
    April 6, 2022
    Last Updated
    May 9, 2022
    Sponsor
    Maharishi International University
    Collaborators
    Charles Drew University of Medicine and Science
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05373732
    Brief Title
    Stress Reduction in the Prevention of Left Ventricular Hypertrophy
    Official Title
    Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1996 (Actual)
    Primary Completion Date
    October 1998 (Actual)
    Study Completion Date
    December 1998 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharishi International University
    Collaborators
    Charles Drew University of Medicine and Science

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluated the effect of stress reduction by Transcendental Meditation (TM) on left ventricular mass compared to a health education control group in pre-hypertensive or hypertensive African-American adults over a six-month intervention period.
    Detailed Description
    Left ventricular hypertrophy (LVH) is an independent risk factor for cardiovascular disease (CVD). African Americans have higher rates of LVH and CVD than whites. Substantial evidence indicates that psychological stress contributes to LVH. This randomized controlled trial evaluated the effect of stress reduction with the Transcendental Meditation (TM) technique on left ventricular mass (LVM) in hypertensive African-Americans. Hypertensive African American men and women were tested at baseline for left ventricular mass index (LVMI) by M-mode echocardiography, blood pressure, lifestyle and behavioral factors. Subjects were randomly assigned to either TM or health education (HE) control. After six months intervention, 86 subjects were posttested on all outcomes. Data were analyzed for between-group and within-group differences.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Left Ventricular Hypertrophy, High Blood Pressure
    Keywords
    left ventricular mass, meditation, stress reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized, controlled, single-blinded, clinical trial was conducted to compare the effect of Transcendental Meditation (TM) and health education (HE) on left ventricular mass in adult hypertensive African-Americans
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Masking Description
    Randomization was stratified by age, gender, mean arterial pressure, left ventricular mass index (LVMI), and antihypertensive medication. Investigators, data collectors and data management staff were blinded to group assignment. The biostatistician concealed the allocation by conveying the group assignment to the project manager who then informed each participant and instructed them not to reveal it to the research and data collection staff during the course of the study.
    Allocation
    Randomized
    Enrollment
    171 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transcendental Meditation
    Arm Type
    Experimental
    Arm Description
    The Transcendental Meditation (TM) technique is described as a simple, natural technique that is practiced twice a day for 20 minutes while sitting comfortably with eyes closed. There are no required changes in lifestyle, beliefs or philosophy. Instruction in the TM technique involves a seven-step course over five sessions (90-minute meetings).
    Arm Title
    Health Education
    Arm Type
    Active Comparator
    Arm Description
    The health education (HE) intervention provided behavioral instructions for CVD risk factor prevention . This group received written materials, structured presentations, didactic instructions and group support for modifying the major cardiovascular risk factors including salt restriction, weight reduction, aerobic exercise, alcohol and smoking cessation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    meditation
    Other Intervention Name(s)
    stress reduction
    Intervention Description
    meditation practice 20 minutes twice a day at home and attending classes at the clinic.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health education control
    Intervention Description
    didactic based classes in CVD risk factor reduction and prevention
    Primary Outcome Measure Information:
    Title
    left ventricular mass (LVM)
    Description
    The primary outcome was change in LVMI. LVM was measured by M-mode echocardiography and indexed by body surface area to generate LVMI. [18] Measurements were obtained at the end-diastole. Interventricular septal thickness, posterior wall thickness, and left ventricle internal dimension were measured.
    Time Frame
    6 months pre to post
    Secondary Outcome Measure Information:
    Title
    blood pressure
    Description
    systolic and diastolic blood pressure
    Time Frame
    0 and 6 months
    Title
    anger expression
    Description
    Speilberger Anger expression scale
    Time Frame
    0 and 6 months
    Title
    perceived stress
    Description
    Perceived Stress Scale, a 5-item subset of the California Self-Evaluation Scale to measure self-esteem, and a personal efficacy scale
    Time Frame
    0 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: self-identified African-American men and women ages, 20-75 years old, with either prehypertension (systolic blood pressure (SBP) of 120-139 mm Hg and/or diastolic blood pressure (DBP) of 80-89 mm Hg), Stage-1 hypertension (SBP of 140-159 mm Hg and/or DBP of 90-99 mm Hg) or Stage-2 hypertension (SBP of 160-179 and/or DBP of 100-109 mm of Hg), with or without antihypertensive medications - Exclusion Criteria: Patients with a history of stroke, transient cerebral ischemic attack, congestive heart failure, myocardial infarction, angina pectoris or with significant ECG abnormalities, major psychiatric or behavioral disorder such as alcoholism (> 28 drinks per week) -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert H Schneider, M.D.
    Organizational Affiliation
    Maharishi International University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD is available on request to authors from other study investigators. Database on Excel is available to be emailed to inquiring investigators
    IPD Sharing Time Frame
    currently available
    IPD Sharing Access Criteria
    contact investigators and request access to database and submit short study proposal
    Citations:
    PubMed Identifier
    31641325
    Citation
    Schneider RH, Myers HF, Marwaha K, Rainforth MA, Salerno JW, Nidich SI, Gaylord-King C, Alexander CN, Norris KC. Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans. Ethn Dis. 2019 Oct 17;29(4):577-586. doi: 10.18865/ed.29.4.577. eCollection 2019 Fall.
    Results Reference
    result

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    Stress Reduction in the Prevention of Left Ventricular Hypertrophy

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