We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01542359
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : January 10, 2013
Information provided by (Responsible Party):
Marshall Hagins, Long Island University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Yogic practice Other: Conventional Exercise Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension
Study Start Date : September 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Ambulatory Blood Pressure [ Time Frame: Assessed within one week post a 12 week intervention ]
    24 hour ambulatory blood pressure: systolic, diastolic

Secondary Outcome Measures :
  1. Psychosocial Stress [ Time Frame: Assessed within one week after 12 week intervention ]
    perceived stress, coping, tolerance of uncertainty, sense of control,

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542359

Layout table for location information
United States, New York
Long Island University
Brooklyn, New York, United States, 11201
Sponsors and Collaborators
Long Island University
Layout table for investigator information
Principal Investigator: Marshall A Hagins, PhD, PT Long Island University
Layout table for additonal information
Responsible Party: Marshall Hagins, Professor, Long Island University
ClinicalTrials.gov Identifier: NCT01542359    
Other Study ID Numbers: 1SC3GM088049-01A1 REVISED
1SC3GM088049-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013
Keywords provided by Marshall Hagins, Long Island University:
Yoga, Hypertension
Blood Pressure
Autonomic Nervous system
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases