The Penn Lifestyle Modification and Blood Pressure Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00328666
First received: May 18, 2006
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Iyengar yoga
Behavioral: Enhanced nutritional care classes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cardiovascular Effects of Iyengar Yoga vs. Enhanced Usual Care in Patients With High-Normal to Stage I Hypertension

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • systolic blood pressure

Secondary Outcome Measures:
  • heart rate variability
  • lipids
  • safety markers
  • quality of life measures
  • physiologic markers of stress
  • insulin resistance
  • pulse wave velocity

Estimated Enrollment: 60
Study Start Date: February 2005
Study Completion Date: January 2007
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328666

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Raymond Townsend, MD University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00328666     History of Changes
Obsolete Identifiers: NCT00271895
Other Study ID Numbers: 802058 LIMBS, NIH grant number AT002353-02
Study First Received: May 18, 2006
Last Updated: May 20, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014