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Lifestyle Modification and Blood Pressure Study - NCT00964847-19104(Clinical Trial 306796)



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City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: High Blood Pressure
Purpose: 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.
Study summary: 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.
Criteria: Inclusion Criteria: - Subjects must be willing and able to give written informed consent. - Age > 18 years, but < 72 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.
Study is available at: Hospital at the University of Pennsylvania
Philadelphia, PA 19104
United States

Primary Contact:
Deborah Bouvier, Ph.D.
Email: upennlimbs@yahoo.com
Phone: 215-615-6570
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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