title: Lifestyle Modification in Blood Pressure Study II (LIMBS): study protocol of a randomized controlled trial assessing the efficacy of a 24 week structured yoga program versus lifestyle modification on blood pressure reduction.
abstract: Hypertension is a major public health issue affecting 68 million adults in the United States. Lifestyle modifications including complementary therapies such as the movement based mind body practice of yoga have become increasingly popular in the United States and have been considered as a potential alternative to medication in blood pressure reduction. We completed a pilot study in 2009 which showed meaningful decreases in 24-hour ambulatory blood pressure readings after a 12 week period of yoga participation. Based on data from our pilot study we are now completing The Lifestyle Modification and Blood Pressure Study (LIMBS II) which is a phase 2 randomized controlled trial designed to determine the effects of yoga therapy and enhanced lifestyle modification on lowering blood pressure in pre-hypertensive and stage 1 hypertensive subjects. Using 24-hour ambulatory blood pressure monitoring, LIMBS II aims to compare the effects on blood pressure reduction in subjects randomized for 24 weeks to one of the three following groups: yoga therapy versus blood pressure education program (sodium restriction and walking program) versus a combination program that involves components of both groups. LIMBS II will also examine the impact that changes in blood pressure have on cerebral blood flow. If successful, the LIMBS study will determine if yoga therapy combined with enhanced lifestyle modification will result in clinically meaningful decreases in blood pressure and thus can be implemented as an alternative to drug therapy for patients with prehypertension and stage 1 hypertension.
authors.affiliation: Perelman School of Medicine at the University of Pennsylvania, Department of Medicine, Renal, Electrolyte and Hypertension Division, Philadelphia, PA 190104, USA. debbie.cohen@uphs.upenn.edu
authors.forename: Debbie L
authors.initials: DL
authors.lastname: Cohen
authors.forename: Anne
authors.initials: A
authors.lastname: Bowler
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Fisher
authors.forename: Angela
authors.initials: A
authors.lastname: Norris
authors.forename: Andrew
authors.initials: A
authors.lastname: Newberg
authors.forename: Hengyi
authors.initials: H
authors.lastname: Rao
authors.forename: Rupal
authors.initials: R
authors.lastname: Bhavsar
authors.forename: John A
authors.initials: JA
authors.lastname: Detre
authors.forename: Thomas
authors.initials: T
authors.lastname: Tenhave
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Townsend
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001774:Blood Chemical Analysis; D001794:Blood Pressure; D015992:Body Mass Index; D005260:Female; D015438:Health Behavior; D006801:Humans; D006973:Hypertension / Q000517:prevention & control / Q000628:therapy; D008019:Life Style; D008297:Male; D008875:Middle Aged; D012107:Research Design; D016482:Urinalysis; D015013:Yoga; D055815:Young Adult
keywords: Functional MRI; Hypertension; Phase 2 clinical randomized trial; Prehypertension; Yoga