Status:
COMPLETED
Lifestyle Modification and Blood Pressure Study
Lead Sponsor:
University of Pennsylvania
Conditions:
High Blood Pressure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 pressu...
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00964847
Start Date
August 1 2009
End Date
June 1 2015
Last Update
February 15 2017
Active Locations (1)
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1
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104