Left Ventricular Hypertrophy, High Blood Pressure
Conditions
Keywords
left ventricular mass, meditation, stress reduction
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.
Interventions
BEHAVIORALmeditation
meditation practice 20 minutes twice a day at home and attending classes at the clinic.
BEHAVIORALHealth education control
didactic based classes in CVD risk factor reduction and prevention
Sponsors
Charles Drew University of Medicine and Science
Maharishi International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes 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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular mass (LVM) | 6 months pre to post | 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
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | 0 and 6 months | systolic and diastolic blood pressure |
| anger expression | 0 and 6 months | Speilberger Anger expression scale |
| perceived stress | 0 and 6 months | Perceived Stress Scale, a 5-item subset of the California Self-Evaluation Scale to measure self-esteem, and a personal efficacy scale |
Outcome results
None listed