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

This study is currently recruiting participants.
Verified February 2012 by Long Island University
Sponsor:
Information provided by (Responsible Party):
Marshall Hagins, Long Island University
ClinicalTrials.gov Identifier:
NCT01542359
First received: February 19, 2012
Last updated: February 25, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Hypertension
 Other: Yogic practice
Other: Conventional Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Long Island University:

Primary Outcome Measures:
  • Ambulatory Blood Pressure [ Time Frame: Assessed within one week post a 12 week intervention ] [ Designated as safety issue: No ]
    24 hour ambulatory blood pressure: systolic, diastolic


Secondary Outcome Measures:
  • Psychosocial Stress [ Time Frame: Assessed within one week after 12 week intervention ] [ Designated as safety issue: No ]
    perceived stress, coping, tolerance of uncertainty, sense of control,


Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542359

Locations
United States, New York
Long Island University Recruiting
Brooklyn, New York, United States, 11201
Contact: Marshall A Hagins, PhD     347-804-8512     mhagins@liu.edu    
Principal Investigator: Marshall Hagins, PhD            
Sponsors and Collaborators
Long Island University
  More Information

No publications provided

Responsible Party: Marshall Hagins, Professor, Long Island University
ClinicalTrials.gov Identifier: NCT01542359     History of Changes
Other Study ID Numbers: 1SC3GM088049-01A1 REVISED
Study First Received: February 19, 2012
Last Updated: February 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Long Island University:
Yoga, Hypertension
Blood Pressure
Autonomic Nervous system

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2012