Completed

Stress Reduction & CVD Morbidity and Mortality in Blacks

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What is being tested

meditation

+ relaxation
Behavioral
Who is being recruted

Cardiovascular Diseases
+1

+ Heart Diseases
+ Hypertension
From 55 to 80 Years
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: July 1992

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: July 24, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 1992Actual date on which the first participant was enrolled.

To compare the effects of two stress reduction techniques, Transcendental Meditation (TM) and Progressive Muscle Relaxation (PMR), on the control of mild hypertension in elderly Blacks with hypertension. BACKGROUND: Life expectancy for Black Americans is about 10 percent less than for whites. The leading cause of excessive mortality in older Blacks is cardiovascular disease which may be largely due to disproportionately high rates of hypertension in older Blacks. Conventional antihypertensive drug therapies are frequently associated with adverse effects on quality-of-life (QL) and low compliance rates, especially in elderly minority populations. The present study is an extension of a pilot study on a comparable sample of 80 Black elderly. The previous study, which was the first of its kind, yielded results which indicated that both TM and PMR produced moderate reductions in systolic and diastolic blood pressure, with TM producing the most significant improvements in blood pressure and in quality-of-life. Dr. Schneider hypothesized from this and related evidence that TM should prove to be an effective therapeutic adjunct to regular pharmacotherapy for mild hypertension in elderly Blacks, and should prove even more effective in fostering compliance and in improving overall quality-of-life without any of the unpleasant side effects of anti-hypertensive medications. DESIGN NARRATIVE: Randomized. Over an 18-month period, 213 people were screened for inclusion in the study. Of these, 127 with initial diastolic blood pressure of 90 to 109 mm Hg, systolic blood pressure of 189 mm Hg or less, and final baseline blood pressure of 179/104 or less mm Hg were randomized to treatment. Of the 127 participants, 16 did not complete follow-up blood pressure measurements. Thus, 111 subjects completed the study. All subjects were pretested over a four session baseline period on clinic blood pressure, ambulatory blood pressure, cardiovascular and emotional reactivity, and quality-of-life measures. Subjects were then randomly assigned, 36 to TM, 37 to PMR, and 38 to lifestyle modification education control and followed monthly with major post-tests at three months and eighteen months on these variables. The primary outcome variables were changes in clinic systolic and diastolic blood pressure values measured blindly. The secondary outcomes were changes in self-monitored home blood pressure and compliance. The study was extended through July, 2007 for an additional 5 years of followup of the cohort.

Official TitleStress Reduction & CVD Morbidity and Mortality in Blacks 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: July 24, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 55 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Criteria

Inner-city Blacks with mild hypertension



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers