The Penn Lifestyle Modification and Blood Pressure Study

NCT00328666 | Completed

• 2 other identifiers: 802058 LIMBSNIH grant number AT002353-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure

Secondary Outcomes (7)

• heart rate variability

• lipids

• safety markers

• quality of life measures

• physiologic markers of stress

Interventions

Iyengar yoga BEHAVIORAL

Enhanced nutritional care classes BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raymond Townsend, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 22, 2006
• Study Start: February 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

US (1)