Clinical trial NCT00681200: Evaluating Mechanisms of Blood Pressure Reduction Using Meditation in Hypertensive African Americans
Official title: Mechanisms of Meditation in Hypertension in Blacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Blood Pressure Reduction
Stress Reactivity and Recovery
Meditation
Transcendental Meditation
Stress Reduction
Stress Management
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: Howard University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-05-21
Enrollment: 152
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: High blood pressure is a common health problem among people in the United States. This study will compare the effectiveness of a meditation program versus a health education program at decreasing stress and lowering blood pressure levels among African-American adults with high blood pressure.

Detailed description: Hypertension, also known as high blood pressure, is one of the most common health problems among adults, particularly African Americans. If left untreated, it can lead to heart failure, kidney failure, or stroke. High blood pressure can be caused by many factors, including stress, diet, diabetes, kidney disease, or obesity. Typical treatments include taking medication, losing weight, and quitting smoking. Meditation may also be an effective way to decrease stress levels and lower blood pressure. This study will examine the effects of a specific type of meditation, Transcendental Meditation (TM), on stress and blood pressure levels. In previous studies, TM has been shown to have a positive effect on reducing blood pressure levels, but more research is needed to confirm these benefits. This study will compare the effectiveness of a TM program with an enhanced health education (EHE) program for reducing stress and blood pressure levels in African Americans with high blood pressure.

This 4-month study will enroll African Americans with early stage hypertension. Recruiting will be conducted from Howard University Medical Center in Washington, DC. First, participants will take part in 3 days of baseline testing, including a medical history review, blood pressure and heart rate measurements, an echocardiogram to obtain images of the heart, and blood and urine collection. Over a 24-hour period, blood pressure and heart rate will be measured continuously and participants will wear a pedometer to keep track of the distance they walk. Participants will also complete a stress test; a treadmill exercise test; and questionnaires on mental health, physical health, and lifestyle.

After the 3-day baseline period, participants will attend an informational meeting with the study staff and other study participants. They will then be randomly assigned to either the TM group or the EHE group. Participants in the TM group will learn a simple meditation technique over a 6-day period. They will be expected to meditate for 20 minutes twice a day for 4 months. Participants will attend follow-up meetings with a meditation instructor every 2 weeks throughout the study, and they will record their progress in a daily diary. Participants in the EHE program will take part in 14 events during the study, including watching educational films, listening to guest speakers, and participating in other instructional activities that will provide health information about blood pressure regulation. In addition, all participants will attend standard health education classes every 2 weeks. These classes will provide information about reducing the risk factors related to heart disease and stroke. Once a month, participants will attend a study visit and undergo blood pressure and heart rate measurements. At the end of the 4-month study period, all participants will undergo repeat baseline testing.

Eligibility criteria: Inclusion Criteria:

* Self-identifies as African American
* Resides in Washington, DC or surrounding communities
* Has stage I hypertension, defined as systolic blood pressure between 140 and 159 mm Hg and/or diastolic blood pressure between 90 and 99 mm Hg, on average, without taking antihypertensive medications in the sympatholytic class (e.g., beta blockers, alpha antagonists, central nervous system agonists)

Exclusion Criteria:

* Blood pressure levels of less than 140/90 mm Hg or greater than 160/100 mm Hg
* History of clinical cardiovascular disease (e.g., heart attack, angina, intermittent claudication, congestive heart failure, stroke)
* Long-term kidney failure
* Any other life-threatening illness (e.g., advanced cancer)
* History of major psychiatric disorder (e.g., psychosis, dementia, substance abuse disorder)

Primary outcomes:
measure: In-clinic and ambulatory blood pressure
timeFrame: Measured at Month 4
Secondary outcomes:
measure: Cardiovascular hemodynamics and stress hormones
timeFrame: Measured at Month 4
measure: telomerase gene expression
timeFrame: 4 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University College of Medicine
state: District of Columbia
Study officials:
affiliation: Howard University
name: Otelio Randall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duraimani SLC (2012) Lifestyle Modifications and Healthy Biological Aging: Effects of Telomerase Activity and Telomere Length. Ann Arbor Mich: Dissertation Information Service
citation: Duraimani S, Schneider RH, Randall OS, Nidich SI, Xu S, Ketete M, Rainforth MA, Gaylord-King C, Salerno JW, Fagan J. Effects of Lifestyle Modification on Telomerase Gene Expression in Hypertensive Patients: A Pilot Trial of Stress Reduction and Health Education Programs in African Americans. PLoS One. 2015 Nov 16;10(11):e0142689. doi: 10.1371/journal.pone.0142689. eCollection 2015.