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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Yogic practice; Other: Conventional Exercise

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11201
      • Long Island University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga; 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; breathing, meditation, physical postures
Active Comparator: Conventional Exercise; 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; Standard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Long Island University
• Investigators: Principal Investigator: Marshall A Hagins, PhD, PT, Long Island University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 19, 2012
• First Submitted That Met QC Criteria: February 25, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Blood Pressure; Autonomic Nervous system; Yoga, Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 1SC3GM088049-01A1 REVISED; 1SC3GM088049-01A1 (U.S. NIH Grant/Contract)