Clinical trial NCT00328666: The Penn Lifestyle Modification and Blood Pressure Study
Official title: Cardiovascular Effects of Iyengar Yoga vs. Enhanced Usual Care in Patients With High-normal to Stage I Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: systolic blood pressure
Secondary outcomes:
measure: heart rate variability
measure: lipids
measure: safety markers
measure: quality of life measures
measure: physiologic markers of stress
measure: insulin resistance
measure: pulse wave velocity
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Raymond Townsend, MD
role: PRINCIPAL_INVESTIGATOR
References: