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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
August 24, 2009
August 25, 2009
February 15, 2017
August 2009
June 2015   (Final data collection date for primary outcome measure)
24-hour ambulatory blood pressure [ Time Frame: baseline, 12 weeks, 24 weeks ]
Same as current
Complete list of historical versions of study NCT00964847 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lifestyle Modification and Blood Pressure Study
Lifestyle Modification and Blood Pressure 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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
High Blood Pressure
  • 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
  • Active Comparator: Blood pressure education/walking program
    Intervention: Behavioral: Blood pressure education/walking program
  • Active Comparator: Combined intervention
    Interventions:
    • Behavioral: Yoga exercise program
    • Behavioral: Blood pressure education/walking program
  • Experimental: Yoga Exercise Program
    Intervention: Behavioral: Yoga exercise program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00964847
R01AT004921-01A1( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Debbie Cohen, M.D. University of Pennsylvania
University of Pennsylvania
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP