NCT01542359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

February 19, 2012

Last Update Submit

January 8, 2013

Conditions

Hypertension

Keywords

Yoga, HypertensionBlood PressureAutonomic Nervous system

Outcome Measures

Primary Outcomes (1)

  • Ambulatory Blood Pressure

    24 hour ambulatory blood pressure: systolic, diastolic

    Assessed within one week post a 12 week intervention

Secondary Outcomes (1)

  • Psychosocial Stress

    Assessed within one week after 12 week intervention

Study Arms (2)

Yoga

EXPERIMENTAL

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

Conventional Exercise

ACTIVE COMPARATOR

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

Interventions

Yogic practiceOTHER

breathing, meditation, physical postures

Yoga
Conventional ExerciseOTHER

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

Conventional Exercise

Eligibility Criteria

Age21 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Island University

Brooklyn, New York, 11201, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Marshall A Hagins, PhD, PT

    Long Island University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2012

First Posted

March 2, 2012

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

US(1)