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

NCT ID: NCT01542359

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-10-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Yogic practice

Intervention Type: OTHER

breathing, meditation, physical postures

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

Group Type: ACTIVE_COMPARATOR

Conventional Exercise

Intervention Type: OTHER

Standard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts

Interventions

Conventional Exercise

Standard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts

Intervention Type: OTHER

Yogic practice

breathing, meditation, physical postures

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Long Island University

OTHER

Sponsor Role: lead

Responsible Party

Marshall Hagins

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marshall A Hagins, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Long Island University

Locations

Long Island University

Brooklyn, New York, United States

Countries

United States

Other Identifiers

1SC3GM088049-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1SC3GM088049-01A1 REVISED

Identifier Type: -

Identifier Source: org_study_id