Lifestyle Modification and Blood Pressure Study - Full Text View

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:

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure

U.S. FDA Resources

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

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:

Study recruitment website This link exits the ClinicalTrials.gov site

Publications:

Cohen D, Townsend RR. Yoga and hypertension. J Clin Hypertens (Greenwich). 2007 Oct;9(10):800-1. Review. No abstract available.

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.

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. 2009 Sep 4; [Epub ahead of print]

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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Lifestyle Modification and Blood Pressure Study (LIMBS)