MedDataX Logo

The Penn Lifestyle Modification and Blood Pressure Study

NCT ID: NCT00328666

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iyengar yoga

Intervention Type BEHAVIORAL

Enhanced nutritional care classes

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raymond Townsend, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIH grant number AT002353-02

Identifier Type: -

Identifier Source: secondary_id

802058 LIMBS

Identifier Type: -

Identifier Source: org_study_id

NCT00271895

Identifier Type: -

Identifier Source: nct_alias