Lifestyle Modification and Blood Pressure Study

Phase 2

Completed

• Conditions: High Blood Pressure
• Interventions: Behavioral: Yoga exercise program; Behavioral: Blood pressure education/walking program

• Registration Number: NCT00964847
• Lead Sponsor: University of Pennsylvania

Brief 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 subjects.

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined intervention	Yoga exercise program	-
Combined intervention	Blood pressure education/walking program	-
Yoga Exercise Program	Yoga exercise program	-
Blood pressure education/walking program	Blood pressure education/walking program	-

Primary Outcome Measures

Name	Time	Method
24-hour ambulatory blood pressure	baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Name	Time	Method
psychological measures of mood, perceived stress and health competence	baseline, 12 weeks, 24 weeks
serum asymmetric dimethylarginine (ADMA)	baseline, 12 weeks, 24 weeks
salivary cortisol	baseline, 12 weeks, 24 weeks
physiological measures of flexibility	baseline, 12 weeks, 24 weeks
Cerebral blood flow	baseline, 12 weeks, 24 weeks
Urinary Isoprostane	baseline, 12 weeks, 24 weeks

Trial Locations

Locations (1)

Hospital at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States