An interventional study of meditation and Health education control in Left Ventricular Hypertrophy and High Blood Pressure, sponsored by Maharishi International University. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-13.
Sponsored by Maharishi International University · Not applicable, Interventional, and Treatment
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.
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.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's enrollment of 171 is above the median of 100 across 97 interventional studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →Maharishi International University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 abnormalities, major psychiatric or behavioral disorder such as alcoholism (> 28 drinks per week)
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: meditation
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.
Behavioral: Health education control
meditation practice 20 minutes twice a day at home and attending classes at the clinic.
Also known as: stress reduction
didactic based classes in CVD risk factor reduction and prevention
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.
Time frame: 6 months pre to post
blood pressure
systolic and diastolic blood pressure
Time frame: 0 and 6 months
anger expression
Speilberger Anger expression scale
Time frame: 0 and 6 months
perceived stress
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
No study locations are listed for this record.
Plan to share: Yes — IPD is available on request to authors from other study investigators. Database on Excel is available to be emailed to inquiring investigators
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: currently available
Access criteria: contact investigators and request access to database and submit short study proposal
Ran from Apr 1996 to primary completion in Oct 1998, 30 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Hypertrophy, Left Ventricular →
Maharishi International University