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Lifestyle Modification and Blood Pressure Study (LIMBS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00964847
First Posted: August 25, 2009
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
High Blood Pressure Behavioral: Yoga exercise program Behavioral: Blood pressure education/walking program Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lifestyle Modification and Blood Pressure Study

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 24-hour ambulatory blood pressure [ Time Frame: baseline, 12 weeks, 24 weeks ]

Secondary Outcome Measures:
  • Cerebral blood flow [ Time Frame: baseline, 12 weeks, 24 weeks ]
  • Urinary Isoprostane [ Time Frame: baseline, 12 weeks, 24 weeks ]
  • serum asymmetric dimethylarginine (ADMA) [ Time Frame: baseline, 12 weeks, 24 weeks ]
  • salivary cortisol [ Time Frame: baseline, 12 weeks, 24 weeks ]
  • psychological measures of mood, perceived stress and health competence [ Time Frame: baseline, 12 weeks, 24 weeks ]
  • physiological measures of flexibility [ Time Frame: baseline, 12 weeks, 24 weeks ]

Enrollment: 147
Study Start Date: August 2009
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Blood pressure education/walking program Behavioral: Blood pressure education/walking program
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.
Other Name: BPEP
Active Comparator: Combined intervention Behavioral: Yoga exercise program
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.
Other Name: YP
Behavioral: Blood pressure education/walking program
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.
Other Name: BPEP
Experimental: Yoga Exercise Program Behavioral: Yoga exercise program
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.
Other Name: YP

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964847


Locations
United States, Pennsylvania
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Debbie Cohen, M.D. University of Pennsylvania
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00964847     History of Changes
Other Study ID Numbers: R01AT004921-01A1 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2009
First Posted: August 25, 2009
Last Update Posted: February 15, 2017
Last Verified: February 2017

Keywords provided by University of Pennsylvania:
hypertension
cardiovascular disease
yoga

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases


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