NCT00964847

Brief Summary

The purpose of this study is to compare the effects of 24 weeks of either a blood pressure education and walking program versus a yoga exercise program versus the combined intervention of blood pressure education and yoga on reducing mild to moderate high blood pressure in pre-hypertension and stage 1 hypertension subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

5.8 years

First QC Date

August 24, 2009

Last Update Submit

February 13, 2017

Conditions

High Blood Pressure

Keywords

hypertensioncardiovascular diseaseyoga

Outcome Measures

Primary Outcomes (1)

  • 24-hour ambulatory blood pressure

    baseline, 12 weeks, 24 weeks

Secondary Outcomes (6)

  • Cerebral blood flow

    baseline, 12 weeks, 24 weeks

  • Urinary Isoprostane

    baseline, 12 weeks, 24 weeks

  • serum asymmetric dimethylarginine (ADMA)

    baseline, 12 weeks, 24 weeks

  • salivary cortisol

    baseline, 12 weeks, 24 weeks

  • psychological measures of mood, perceived stress and health competence

    baseline, 12 weeks, 24 weeks

  • +1 more secondary outcomes

Study Arms (3)

Blood pressure education/walking program

ACTIVE COMPARATOR
Behavioral: Blood pressure education/walking program

Combined intervention

ACTIVE COMPARATOR
Behavioral: Yoga exercise programBehavioral: Blood pressure education/walking program

Yoga Exercise Program

EXPERIMENTAL
Behavioral: Yoga exercise program

Interventions

Yoga exercise programBEHAVIORAL

Subjects in the yoga exercise program participate in structured bi-weekly 1.5 hour yoga classes held at a yoga studio as well as develop a weekly hour-long home practice over the 6 months of the study.

Also known as: YP
Combined interventionYoga Exercise Program
Blood pressure education/walking programBEHAVIORAL

The program will consist of small group health education classes and a walking program. Subjects will be expected to attend a dietician-led nutrition class twice a month. On alternate weeks the subjects will be given either motivational talks about a variety of topics including weight loss, walking programs, and healthy lifestyle choices or they will be given educational DVDs or literature to read on the weeks that they are not attending a BPEP class. These subjects will all receive 12 nutrition classes and 12 motivational experiences. The subjects will also be expected to walk 6 days a week gradually increasing to 180 minutes of walking per week or 10,000 steps per day.

Also known as: BPEP
Blood pressure education/walking programCombined intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be willing and able to give written informed consent.
  • Age \> 18 years, but \< 75 years.
  • BP criteria: Systolic Blood Pressure (SBP) of \> 130, but \< 160 mm Hg.
  • Willing to comply with all study-related procedures.

You may not qualify if:

  • Subjects who are pregnant or post partum \< 3 months.
  • Subjects currently taking BP lowering medications or dietary supplements (magnesium, potassium, calcium \> 1200 mg/day, fish oils, ephedra, hawthorn, forskolin, etc…).
  • Stage II HTN (SBP \> 160 mmHg OR diastolic blood pressure (DBP) \> 100 mmHg).
  • Non-dominant arm circumference \> 50 cm.
  • BMI \> 40.0 kg/m2.
  • Practicing yoga \>1x/month in the previous 6 months.
  • Received/used experimental drug or device within 30 days prior to screening, or donated blood \> 1 pint within 8 weeks of screening.
  • Diabetes mellitis.
  • Established cardiovascular disease.
  • Known arrhythmias or cardiac pacemakers.
  • Current users (within 30 days) of any tobacco products.
  • History of renal insufficiency (glomerular filtration rate \< 60 ml/min).
  • Women consuming \> 7 alcoholic drinks/week; men consuming \> 14 drinks/week.
  • Known autonomic neuropathy.
  • Known secondary cause of HTN (renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronism).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

  • Cohen D, Townsend RR. Yoga and hypertension. J Clin Hypertens (Greenwich). 2007 Oct;9(10):800-1. doi: 10.1111/j.1751-7176.2007.tb00008.x. No abstract available.

    PMID: 17917509BACKGROUND

  • Cohen DL, Wintering N, Tolles V, Townsend RR, Farrar JT, Galantino ML, Newberg AB. Cerebral blood flow effects of yoga training: preliminary evaluation of 4 cases. J Altern Complement Med. 2009 Jan;15(1):9-14. doi: 10.1089/acm.2008.0008.

    PMID: 19769471BACKGROUND

  • Cohen DL, Bloedon LT, Rothman RL, Farrar JT, Galantino ML, Volger S, Mayor C, Szapary PO, Townsend RR. Iyengar Yoga versus Enhanced Usual Care on Blood Pressure in Patients with Prehypertension to Stage I Hypertension: a Randomized Controlled Trial. Evid Based Complement Alternat Med. 2011;2011:546428. doi: 10.1093/ecam/nep130. Epub 2011 Feb 14.

    PMID: 19734256BACKGROUND

  • Cohen DL, Boudhar S, Bowler A, Townsend RR. Blood Pressure Effects of Yoga, Alone or in Combination With Lifestyle Measures: Results of the Lifestyle Modification and Blood Pressure Study (LIMBS). J Clin Hypertens (Greenwich). 2016 Aug;18(8):809-16. doi: 10.1111/jch.12772. Epub 2016 Jan 15.

    PMID: 26773737DERIVED

  • Cohen DL, Bowler A, Fisher SA, Norris A, Newberg A, Rao H, Bhavsar R, Detre JA, Tenhave T, Townsend RR. Lifestyle Modification in Blood Pressure Study II (LIMBS): study protocol of a randomized controlled trial assessing the efficacy of a 24 week structured yoga program versus lifestyle modification on blood pressure reduction. Contemp Clin Trials. 2013 Sep;36(1):32-40. doi: 10.1016/j.cct.2013.05.010. Epub 2013 May 27.

    PMID: 23721984DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Debbie Cohen, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 15, 2017

Record last verified: 2017-02

Locations

US(1)