Status:
COMPLETED
The Penn Lifestyle Modification and Blood Pressure Study
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the effects of 12 weeks of structured classes of either iyengar yoga (IY) or an enhanced usual care intervention on blood pressure, heart rate variability, qual...
Detailed Description
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 H...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00328666
Start Date
February 1 2005
End Date
January 1 2007
Last Update
November 25 2015
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104