Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328666
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2006-05-18
Brief Title:
The Penn Lifestyle Modification and Blood Pressure Study
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Cardiovascular Effects of Iyengar Yoga vs Enhanced Usual Care in Patients With High-normal to Stage I Hypertension
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH grant number AT002353-02 | None | None | None |