Lifestyle Modification and Blood Pressure Study (LIMBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00964847
First received: August 24, 2009
Last updated: August 4, 2011
Last verified: August 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Lifestyle Modification and Blood Pressure Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 24-hour ambulatory blood pressure [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cerebral blood flow [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Urinary Isoprostane [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • serum asymmetric dimethylarginine (ADMA) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • salivary cortisol [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • psychological measures of mood, perceived stress and health competence [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • physiological measures of flexibility [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964847

Contacts
Contact: Anne Bowler, BA 215-615-6570 Anne.Bowler@uphs.upenn.edu
Contact: Debbie Cohen, M.D. 215-615-0794 Debbie.Cohen@uphs.upenn.edu

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Debbie Cohen, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00964847     History of Changes
Other Study ID Numbers: R01AT004921-01A1
Study First Received: August 24, 2009
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pennsylvania:
hypertension
cardiovascular disease
yoga

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014