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The purpose of this study is to compare the effects of 24 weeks of either a blood pressure education and walking program versus a yoga exercise program versus the combined intervention of blood pressure education and yoga on reducing mild to moderate high blood pressure in pre-hypertension and stage 1 hypertension subjects.
The study is a non-blinded, randomized controlled trial to assess the safety and efficacy of 24 weeks of a structured yoga exercise program (YP) versus a blood pressure education and walking program (BPEP) versus the combined intervention on reducing mild to moderate high blood pressure in adults with pre-hypertension or stage 1 hypertension. This will be done through a single center trial using a parallel design. All potential subjects will be screened first by telephone and then by 2 outpatient visits at the Clinical and Translational Research Center (CTRC) at the hospital of the University of Pennsylvania. Eligible subjects will then make 3 visits to the CTRC where they will be admitted overnight to have non-invasive 24-hour recordings of BP, as well as have periodic blood, urine and saliva collections. The entire study duration is 28 weeks (24 weeks post-randomization) and includes a total of 7 evaluation visits (including 2 functional magnetic resonance imaging visits) and a termination visit. Subjects will be randomized to YP, BPEP or the combined intervention of YP and BPEP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood pressure education/walking program | Active Comparator |
| |
| Combined intervention | Active Comparator |
| |
| Yoga Exercise Program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga exercise program | Behavioral | Subjects in the yoga exercise program participate in structured bi-weekly 1.5 hour yoga classes held at a yoga studio as well as develop a weekly hour-long home practice over the 6 months of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour ambulatory blood pressure | baseline, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral blood flow | baseline, 12 weeks, 24 weeks | |
| Urinary Isoprostane | baseline, 12 weeks, 24 weeks | |
| serum asymmetric dimethylarginine (ADMA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debbie Cohen, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital at the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17917509 | Background | Cohen D, Townsend RR. Yoga and hypertension. J Clin Hypertens (Greenwich). 2007 Oct;9(10):800-1. doi: 10.1111/j.1751-7176.2007.tb00008.x. No abstract available. | |
| 19769471 | Background | Cohen DL, Wintering N, Tolles V, Townsend RR, Farrar JT, Galantino ML, Newberg AB. Cerebral blood flow effects of yoga training: preliminary evaluation of 4 cases. J Altern Complement Med. 2009 Jan;15(1):9-14. doi: 10.1089/acm.2008.0008. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| Blood pressure education/walking program | Behavioral | The program will consist of small group health education classes and a walking program. Subjects will be expected to attend a dietician-led nutrition class twice a month. On alternate weeks the subjects will be given either motivational talks about a variety of topics including weight loss, walking programs, and healthy lifestyle choices or they will be given educational DVDs or literature to read on the weeks that they are not attending a BPEP class. These subjects will all receive 12 nutrition classes and 12 motivational experiences. The subjects will also be expected to walk 6 days a week gradually increasing to 180 minutes of walking per week or 10,000 steps per day. |
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| baseline, 12 weeks, 24 weeks |
| salivary cortisol | baseline, 12 weeks, 24 weeks |
| psychological measures of mood, perceived stress and health competence | baseline, 12 weeks, 24 weeks |
| physiological measures of flexibility | baseline, 12 weeks, 24 weeks |
| 19734256 | Background | Cohen DL, Bloedon LT, Rothman RL, Farrar JT, Galantino ML, Volger S, Mayor C, Szapary PO, Townsend RR. Iyengar Yoga versus Enhanced Usual Care on Blood Pressure in Patients with Prehypertension to Stage I Hypertension: a Randomized Controlled Trial. Evid Based Complement Alternat Med. 2011;2011:546428. doi: 10.1093/ecam/nep130. Epub 2011 Feb 14. |
| 26773737 | Derived | Cohen DL, Boudhar S, Bowler A, Townsend RR. Blood Pressure Effects of Yoga, Alone or in Combination With Lifestyle Measures: Results of the Lifestyle Modification and Blood Pressure Study (LIMBS). J Clin Hypertens (Greenwich). 2016 Aug;18(8):809-16. doi: 10.1111/jch.12772. Epub 2016 Jan 15. |
| 23721984 | Derived | Cohen DL, Bowler A, Fisher SA, Norris A, Newberg A, Rao H, Bhavsar R, Detre JA, Tenhave T, Townsend RR. Lifestyle Modification in Blood Pressure Study II (LIMBS): study protocol of a randomized controlled trial assessing the efficacy of a 24 week structured yoga program versus lifestyle modification on blood pressure reduction. Contemp Clin Trials. 2013 Sep;36(1):32-40. doi: 10.1016/j.cct.2013.05.010. Epub 2013 May 27. |