Lifestyle Modification and Blood Pressure Study

Lifestyle Modification and Blood Pressure Study

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.

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.