Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension

Study Overview
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Brief Summary
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The proposed study will compare a well defined and integrated yoga practice (postures/breath control/meditation) to a conventional exercise program in reducing hypertension. The expected outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial stress, and the autonomic system in individuals with pre- and Stage I hypertension. The information gained in this study will have a positive impact by providing critical preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial on the effects of yoga on individuals with hypertension.

Official Title
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Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Other: Yogic practice
* Other: Conventional Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 21-64; Pre- or Stage I hypertension with mean office blood pressure (two measurements using aneroid sphygmomanometer) of systolic between 120 and 159 mmHg or Diastolic between less than or equal to 80 and 99 [1] Medically stable on any current medications; BMI (kg/m2) between 18.5 - 40 English speaking Exclusion Criteria: Taking anti-hypertensive medication; Current use of insulin or oral hypoglycemic agents Previous cardiovascular event (prior myocardial infarction, stroke, or angina pectoris) Current or previous cancer diagnosis Congestive heart failure History of kidney disease Signs or symptoms of significant peripheral vascular disease Significant co-morbidities that preclude successful completion of the study Yoga practitioner (participated in more than 3 yoga sessions within the last year)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 74 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>The integrated yoga program was designed to: 1) include the three primary elements of yoga as most commonly practiced in western cultures (physical postures, breath control and meditation); and 2) be appropriate for those without any prior yoga experience and with pre- and Stage I hypertension. The yoga program was designed by Eddie Stern, Founder and Director of Ashtanga Yoga New York (AYNY) in consultation with Drs. Hagins and Rundle, and are in large part congruent with the yoga program we studied previously (see Preliminary Studies). The yoga class includes: instruction on yogic principles regarding moral precepts (yamas and niyamas); active postures requiring mild-moderate physical exertion; conscious control of the breath in synchrony with active postures; and meditation. We expect approximately 10-15 minutes of the integrated yoga program to consist of isolated practice of meditation (occurring independently of the moving postures, typically in seated or lying positions). | Other: Yogic practice<br>* breathing, meditation, physical postures<br>|
| Active Comparator: Conventional Exercise<br>Conventional exercise such as standing toe touch with arm swings, curl ups, push ups, leg lifts, etc. All done at a relatively slow rate which will be non-aerobic and at an average rate across the session of 3 METs | Other: Conventional Exercise<br>* Standard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory Blood Pressure | 24 hour ambulatory blood pressure: systolic, diastolic | Assessed within one week post a 12 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial Stress | perceived stress, coping, tolerance of uncertainty, sense of control, | Assessed within one week after 12 week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, Hypertension, Blood Pressure, Autonomic Nervous system