Evaluating Mechanisms of Blood Pressure Reduction Using Meditation in Hypertensive African Americans

Hypertension Clinical Trial

— HMEC  

Official title:

Mechanisms of Meditation in Hypertension in Blacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681200
• Other study ID #: 602
• Secondary ID: R01HL083944-01A1
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: May 2012

Study information

• Verified date: April 2022
• Source: Maharishi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Enhanced health education
health education and social support
• Transcendental Meditation program
The TM program plus didactic-based health education classes

Locations

Country	Name	City	State
United States	Howard University College of Medicine	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Maharishi International University	Howard University, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Edu — View Citation

Duraimani SLC (2012) Lifestyle Modifications and Healthy Biological Aging: Effects of Telomerase Activity and Telomere Length. Ann Arbor Mich: Dissertation Information Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-clinic and ambulatory blood pressure		Measured at Month 4
Secondary	Cardiovascular hemodynamics and stress hormones		Measured at Month 4
Secondary	telomerase gene expression	telomerase gene expression as measured HTERT and HTR	4 months