Lifestyle Modification and Blood Pressure Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- 24-hour ambulatory blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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/m
- •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.
结局指标
主要结局
24-hour ambulatory blood pressure
时间窗: baseline, 12 weeks, 24 weeks
次要结局
- 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)