Lifestyle Modification and Blood Pressure Study

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.