Lifestyle Modification and Blood Pressure Study

Completed · Phase 2

Conditions studied: High Blood Pressure

In brief

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.

Key facts

Study ID

NCT00964847

Run by

University of Pennsylvania

People needed

147

Starts

2009-08-01

Expected to finish

2015-06-01

Last updated by the study team

2017-02-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital at the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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