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High Blood PressurePhase 2LIMBSNCT00964847

Lifestyle Modification and Blood Pressure Study

A Phase 2 study testing Yoga exercise program and Blood pressure education/walking program in people with High Blood Pressure, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
High Blood Pressure
What is being tested?
Yoga exercise program and Blood pressure education/walking program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteUnited States
Study dates
Aug 2009to Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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).
  • Benzodiazepine, anti-psychotic drugs (3 month stable use of SSRIs are allowed), or steroid use.
  • Known severe musculoskeletal problems such as spinal stenosis that may limit participation in yoga.
  • Use of other mind/ body therapies such as Qi Gong, Tai Chi, meditation.
  • Lack Internet access.
  • Presence of non-removable metallic foreign object, surgically implanted electrical device, surgically placed metallic clip (aneurysm clip), ear implants, any history of metal implants in the eye.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital at the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the detailed description

The study is a non-blinded, randomized controlled trial to assess the safety and efficacy of 24 weeks of a structured yoga exercise program (YP) versus a blood pressure education and walking program (BPEP) versus the combined intervention on reducing mild to moderate high blood pressure in adults with pre-hypertension or stage 1 hypertension. This will be done through a single center trial using a parallel design. All potential subjects will be screened first by telephone and then by 2 outpatient visits at the Clinical and Translational Research Center (CTRC) at the hospital of the University of Pennsylvania. Eligible subjects will then make 3 visits to the CTRC where they will be admitted overnight to have non-invasive 24-hour recordings of BP, as well as have periodic blood, urine and saliva collections. The entire study duration is 28 weeks (24 weeks post-randomization) and includes a total of 7 evaluation visits (including 2 functional magnetic resonance imaging visits) and a termination visit. Subjects will be randomized to YP, BPEP or the combined intervention of YP and BPEP.

Being tested
Yoga exercise program, Blood pressure education/walking program
Keywords
hypertension, cardiovascular disease, yoga
Medical subject headings
Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga exercise programBehavioural

    Also called YP

    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.

  • Blood pressure education/walking programBehavioural

    Also called BPEP

    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.

Study groups in NCT00964847
Study groupRoleWhat they receive
Blood pressure education/walking programActive comparatorNot described
Receives: Behavioral: Blood pressure education/walking program
Combined interventionActive comparatorNot described
Receives: Behavioral: Yoga exercise program; Behavioral: Blood pressure education/walking program
Yoga Exercise ProgramExperimentalNot described
Receives: Behavioral: Yoga exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour ambulatory blood pressure

    Measured: baseline, 12 weeks, 24 weeks

Secondary outcomes (6)

  1. Cerebral blood flow

    Measured: baseline, 12 weeks, 24 weeks

  2. Urinary Isoprostane

    Measured: baseline, 12 weeks, 24 weeks

  3. serum asymmetric dimethylarginine (ADMA)

    Measured: baseline, 12 weeks, 24 weeks

  4. salivary cortisol

    Measured: baseline, 12 weeks, 24 weeks

  5. psychological measures of mood, perceived stress and health competence

    Measured: baseline, 12 weeks, 24 weeks

  6. physiological measures of flexibility

    Measured: baseline, 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00964847
Sponsor's protocol ID
R01AT004921-01A1
Acronym
LIMBS
Status last verified
Feb 2017
First submitted
24 Aug 2009
Last updated
15 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17917509

  • 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.

    PubMed 19769471

  • 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.

    PubMed 19734256

  • 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.

    PubMed 26773737

  • 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.

    PubMed 23721984

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Yoga exercise program and Blood pressure education/walking program in people with High Blood Pressure, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour ambulatory blood pressure (time frame: baseline, 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00964847, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.

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