Lifestyle Modification and Blood Pressure Study (LIMBS)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
147 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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