Lifestyle Modification and Blood Pressure Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lifestyle Modification and Blood Pressure Study

Conditions
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High Blood Pressure

Intervention / Treatment
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* Behavioral: Yoga exercise program
* Behavioral: Blood pressure education/walking program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blood pressure education/walking program<br> | Behavioral: Blood pressure education/walking program<br>* 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.<br>* Other names: BPEP;|
| Active Comparator: Combined intervention<br> | Behavioral: Yoga exercise program<br>* 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.<br>* Other names: YP;Behavioral: Blood pressure education/walking program<br>* 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.<br>* Other names: BPEP;|
| Experimental: Yoga Exercise Program<br> | Behavioral: Yoga exercise program<br>* 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.<br>* Other names: YP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour ambulatory blood pressure |  | baseline, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral blood flow |  | baseline, 12 weeks, 24 weeks | 
| Urinary Isoprostane |  | baseline, 12 weeks, 24 weeks | 
| serum asymmetric dimethylarginine (ADMA) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, cardiovascular disease, yoga