Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00328666
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.
Study:
NCT00328666
Study Brief:
Protocol Section:
NCT00328666