Hypertension affects approximately 50 million Americans (24% of the population) and 1 billion individuals worldwide. Hypertension is a potent, consistent and independent risk factor for stroke, heart failure, myocardial infarction and kidney disease. Earlier this year, the Joint National Committee (JNC7) updated its recommendation on the evaluation and management of hypertension. Among the findings of JNC7, the committee emphasized the importance of systolic blood pressure (SBP) and identified a new category of prehypertensive patients who are candidates for effective lifestyle therapies to reduce their cardiovascular risk. Among lifestyle therapies for elevated blood pressure, much of the research to date has been on dietary (low sodium) and activity advice, and dietary supplements (garlic, fish oils). However, mind-body therapies (MBT) such as mediation and yoga are gaining popularity in managing elevations in blood pressure. Yoga is particularly attractive since its popularity and acceptability is rapidly growing in this country, as well as because its multimodal approach, combining postures (asanas), breathing (pranayama) and meditation, lyengar yoga is a particular form of classical therapeutic yoga which relies on tightly scripted asanas which can be standardized, and easily replicated. For this study, we propose to rigorously and scientifically investigate the safety and efficacy of a structured 12 week lyengar Yoga program (IYP) in patients with high-normal to stage I hypertension via a randomized clinical trial using an enhanced usual care comparator group on 3 specific areas. 1) The primary endpoint of this study will be to quantify the effect of the IYP on mean daytime SBP obtained from 24 hour ambulatory blood pressure monitoring (ABPM). 2) The secondary endpoint will be to compare the effects of IYP on heart rate variability (HRV), a measure of cardiac autonomic activity and another important surrogate marker of cardiovascular risk. 3) Finally, we will assess the effects of IYP on physiologic and psychological measures of mood, perceived stress and health related quality of life. By using gold-standard measures of blood pressure and HRV, and collaborating with a network of highly skilled certified lyengar yoga practitioners, we will be able to estimate the true effect of lyengar yoga on SBP, and begin to elucidate mechanisms of this effect. This trial will also generate ample preliminary data for RO1 submissions to allow direct comparisons of lyengar yoga against other non-movement MBTs such as transcendental meditation, established lifestyle recommendations such as the DASH diet, or active pharmacologic control. ? ?

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21AT002353-02
Application #
6947936
Study Section
Special Emphasis Panel (ZAT1-G (11))
Program Officer
Wong, Shan S
Project Start
2004-09-15
Project End
2007-07-31
Budget Start
2005-08-01
Budget End
2006-07-31
Support Year
2
Fiscal Year
2005
Total Cost
$275,795
Indirect Cost
Name
University of Pennsylvania
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104