The Penn Lifestyle Modification and Blood Pressure Study

This is a single site, parallel, non-blinded, randomized controlled trial to assess the
safety and efficacy of 12 weeks of structured IY vs. enhanced usual care in adults with
high-normal to stage I HTN. All potential subjects will be screened first by telephone and
then by an outpatient visit at the General Clinical Research Center (GCRC) at either the
hospital of the University of Pennsylvania (HUP) or the Presbyterian Medical Center (PMC).
Eligible subjects will then make 4 visits to the GCRC where, during 3 visits, they will be
admitted overnight to have non-invasive 24 hour recordings of blood pressure and heart rate
variability as well as periodic blood and urine collections. In order to assess durability
of biologic effects once the formal intervention is stopped, we added a 4 week follow up
visit. The entire study duration is 18 weeks (16 weeks post-randomization) and includes a
total of 5 visits. Subjects will be randomized to either the IYP or Blood Pressure Education
Program (BPEP) which will be incorporated into off-site, small group classes.

Inclusion Criteria:

- Subjects must be willing to, and have the capacity for, giving written informed
consent.

- Between the ages of 18 and 70

- Blood pressure (BP) criteria: systolic blood pressure (SBP) of > 130 but < 160 mm Hg
and diastolic blood pressure (DBP) < 100 mmHg

- All subjects must be willing to comply with all study-related procedures.

Exclusion Criteria:

- Female subjects who are pregnant or post partum < 3 months

- Subjects currently taking blood pressure lowering medications or dietary supplements
(magnesium, potassium, calcium > 1200 mg/day, fish oils > 2000 mg/day, ephedra,
hawthorn, forskolin)

- Non-dominant arm circumference > 50 cm

- Subjects with body mass index (BMI) >= 40.0 or < 18.5 kg/m2

- Subjects who have practiced IY in the last 12 months or those who have practiced any
form of yoga > 2 times (2x)/month in the previous 6 months.

- Subjects who have received an experimental drug, used an experimental medical device
within 30 days prior to screening, or who gave a blood donation of greater than or
equal to one pint within 8 weeks prior to screening.

- Subjects with diabetes mellitus

- Subjects with established cardiovascular disease

- Subjects with known arrhythmias such as atrial flutter or fibrillation or those with
cardiac pacemakers

- Current users (within the previous 30 days) of any tobacco products

- History of renal insufficiency based on estimated glomerular filtration rate < 60
ml/min

- Women who consume > 10 alcoholic drinks per week and men who consume > 15 drinks per
week.

- Subjects with known autonomic neuropathy (e.g: Shy-Drager, orthostatic hypotension)

- Subjects with known secondary causes of hypertension (renal artery stenosis,
pheochromocytoma, coarctation of aorta, hyperaldosteronemia)

- Regular use of benzodiazepines, anti-psychotic drugs or corticosteroids (> 1x per
month). Stable doses (3 months) of antidepressants (selective serotonin reuptake
inhibitors [SSRIs] or tricyclic antidepressants [TCAs]) will be allowed.

- Known severe musculoskeletal problems such as spinal stenosis that may limit
participation in yoga

- Subjects who actively practice (> 2x/month) other mind-body therapy (MBT) such as
Qigong, Tai Chi, or meditation.