Clinical trial NCT00964847: Lifestyle Modification and Blood Pressure Study
Official title: Lifestyle Modification and Blood Pressure Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: High Blood Pressure
Keywords: hypertension
cardiovascular disease
yoga
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects must be willing and able to give written informed consent.
* Age \> 18 years, but \< 75 years.
* BP criteria: Systolic Blood Pressure (SBP) of \> 130, but \< 160 mm Hg.
* Willing to comply with all study-related procedures.

Exclusion Criteria:

* Subjects who are pregnant or post partum \< 3 months.
* Subjects currently taking BP lowering medications or dietary supplements (magnesium, potassium, calcium \> 1200 mg/day, fish oils, ephedra, hawthorn, forskolin, etc...).
* Stage II HTN (SBP \> 160 mmHg OR diastolic blood pressure (DBP) \> 100 mmHg).
* Non-dominant arm circumference \> 50 cm.
* BMI \> 40.0 kg/m2.
* Practicing yoga \>1x/month in the previous 6 months.
* Received/used experimental drug or device within 30 days prior to screening, or donated blood \> 1 pint within 8 weeks of screening.
* Diabetes mellitis.
* Established cardiovascular disease.
* Known arrhythmias or cardiac pacemakers.
* Current users (within 30 days) of any tobacco products.
* History of renal insufficiency (glomerular filtration rate \< 60 ml/min).
* Women consuming \> 7 alcoholic drinks/week; men consuming \> 14 drinks/week.
* Known autonomic neuropathy.
* Known secondary cause of HTN (renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronism).
* Benzodiazepine, anti-psychotic drugs (3 month stable use of SSRIs are allowed), or steroid use.
* Known severe musculoskeletal problems such as spinal stenosis that may limit participation in yoga.
* Use of other mind/ body therapies such as Qi Gong, Tai Chi, meditation.
* Lack Internet access.
* Presence of non-removable metallic foreign object, surgically implanted electrical device, surgically placed metallic clip (aneurysm clip), ear implants, any history of metal implants in the eye.

Primary outcomes:
measure: 24-hour ambulatory blood pressure
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Cerebral blood flow
timeFrame: baseline, 12 weeks, 24 weeks
measure: Urinary Isoprostane
timeFrame: baseline, 12 weeks, 24 weeks
measure: serum asymmetric dimethylarginine (ADMA)
timeFrame: baseline, 12 weeks, 24 weeks
measure: salivary cortisol
timeFrame: baseline, 12 weeks, 24 weeks
measure: psychological measures of mood, perceived stress and health competence
timeFrame: baseline, 12 weeks, 24 weeks
measure: physiological measures of flexibility
timeFrame: baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Debbie Cohen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.