Full Text View
Tabular View
No Study Results Posted
Related Studies
The Penn Lifestyle Modification and Blood Pressure Study
This study has been completed.
Study NCT00328666   Information provided by University of Pennsylvania
First Received: May 18, 2006   Last Updated: May 20, 2008   History of Changes

May 18, 2006
May 20, 2008
February 2005
 
systolic blood pressure
Same as current
Complete list of historical versions of study NCT00328666 on ClinicalTrials.gov Archive Site
  • heart rate variability
  • lipids
  • safety markers
  • quality of life measures
  • physiologic markers of stress
  • insulin resistance
  • pulse wave velocity
heart rate variability, lipids, safety markers, quality of life measures, physiologic markers of stress, insulin resistance, pulse wave velocity
 
The Penn Lifestyle Modification and Blood Pressure Study
Cardiovascular Effects of Iyengar Yoga vs. Enhanced Usual Care in Patients With High-Normal to Stage I Hypertension

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, quality of life measures, lipid measures, and safety in patients with high-normal to stage I hypertension.

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.

 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Hypertension
  • Behavioral: Iyengar yoga
  • Behavioral: Enhanced nutritional care classes
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
January 2007
 

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00328666
 
802058 LIMBS, NIH grant number AT002353-02
University of Pennsylvania
National Institutes of Health (NIH)
Principal Investigator: Raymond Townsend, MD University of Pennsylvania
University of Pennsylvania
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP