lifestyle modification and blood pressure study

Conditions: High Blood Pressure

Summary: the purpose of this study is to compare the effects of 24 weeks of either a blood pressure education and walking program versus a yoga exercise program versus the combined intervention of blood pressure education and yoga on reducing mild to moderate high blood pressure in pre-hypertension and stage 1 hypertension subjects.

the study is a non-blinded, randomized controlled trial to assess the safety and efficacy of 24 weeks of a structured yoga exercise program (yp) versus a blood pressure education and walking program (bpep) versus the combined intervention on reducing mild to moderate high blood pressure in adults with pre-hypertension or stage 1 hypertension. this will be done through a single center trial using a parallel design. all potential subjects will be screened first by telephone and then by 2 outpatient visits at the clinical and translational research center (ctrc) at the hospital of the university of pennsylvania. eligible subjects will then make 3 visits to the ctrc where they will be admitted overnight to have non-invasive 24-hour recordings of bp, as well as have periodic blood, urine and saliva collections. the entire study duration is 28 weeks (24 weeks post-randomization) and includes a total of 7 evaluation visits (including 2 functional magnetic resonance imaging visits) and a termination visit. subjects will be randomized to yp, bpep or the combined intervention of yp and bpep.

Eligibility criteria:
inclusion criteria: * subjects must be willing and able to give written informed consent. * age \> 18 years, but \< 75 years. * bp criteria: systolic blood pressure (sbp) of \> 130, but \< 160 mm hg. * willing to comply with all study-related procedures. exclusion criteria: * subjects who are pregnant or post partum \< 3 months. * subjects currently taking bp lowering medications or dietary supplements (magnesium, potassium, calcium \> 1200 mg/day, fish oils, ephedra, hawthorn, forskolin, etc...). * stage ii htn (sbp \> 160 mmhg or diastolic blood pressure (dbp) \> 100 mmhg). * non-dominant arm circumference \> 50 cm. * bmi \> 40.0 kg/m2. * practicing yoga \>1x/month in the previous 6 months. * received/used experimental drug or device within 30 days prior to screening, or donated blood \> 1 pint within 8 weeks of screening. * diabetes mellitis. * established cardiovascular disease. * known arrhythmias or cardiac pacemakers. * current users (within 30 days) of any tobacco products. * history of renal insufficiency (glomerular filtration rate \< 60 ml/min). * women consuming \> 7 alcoholic drinks/week; men consuming \> 14 drinks/week. * known autonomic neuropathy. * known secondary cause of htn (renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronism). * benzodiazepine, anti-psychotic drugs (3 month stable use of ssris are allowed), or steroid use. * known severe musculoskeletal problems such as spinal stenosis that may limit participation in yoga. * use of other mind/ body therapies such as qi gong, tai chi, meditation. * lack internet access. * presence of non-removable metallic foreign object, surgically implanted electrical device, surgically placed metallic clip (aneurysm clip), ear implants, any history of metal implants in the eye.

Keywords: hypertension cardiovascular disease yoga