NCT00825526已完成不适用
HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 4
- 主要终点
- The primary outcome is the difference in 24-hour systolic and diastolic blood pressure between the treatment and wait-list group for the 12-week primary assessment period.
研究概览
简要总结
The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an effective intervention for lowering blood pressure in early unmedicated hypertensives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 to 75 years
- •Hypertension by ABPM at baseline (daytime > 135/85 mmHg or 24-hour ABPM > 130/80 mmHg)
排除标准
- •Use of antihypertensive within 6 months of the screening ABPM.
- •Screening office BP > 180/100 and ABPM > 160/100 mmHg.
- •Secondary hypertension
- •Renal disease (GFR < 60 ml/min or overt nephropathy)
- •History of heart attack
- •Stroke or TIA or
- •Re-vascularization procedure.
- •Active malignant disease (except non-melanoma skin cancer)
- •Epileptic seizure 6 months before the screening visit.
- •Congestive heart failure
- •Severe liver disease
- •Pregnancy or lactation period
- •Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.
- •Planned elective surgery during the study period except for cataract surgery
结局指标
主要结局
The primary outcome is the difference in 24-hour systolic and diastolic blood pressure between the treatment and wait-list group for the 12-week primary assessment period.
时间窗: 12 weeks
次要结局
- Changes in 24 hour ambulatory systolic and diastolic blood pressure at the end of the treatment assessment period compared to the beginning.(12 weeks)
- Between and within group comparisons of MBSR on blood pressure at different times of the day including daytime, night time and work time.(24 weeks)
- The proportion of patients achieving blood pressure targets (24-hour ABPM<130/80 mmHg, daytime ABPM<135/85 mmHg) at the end of the Primary Outcome period(24 weeks)
- The effect of MBSR on ambulatory blood pressure by gender(24 weeks)
研究者
Sheldon Tobe
Medical Doctor
Sunnybrook Health Sciences Centre
研究点 (4)
Loading locations...
相似试验
已完成
不适用
The Effect of Mindfulness-Based Stress Reduction on Maternal Perceived Milk SupplyBreastfeedingNCT06668467Saglik Bilimleri Universitesi100
已完成
不适用
The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain InjuryTraumatic Brain InjuryStressBrain InjuryNCT01613872Spaulding Rehabilitation Hospital8
已完成
不适用
The Effect of a Mindfulness-Based Stress Reduction Program in Patients With Multiple SclerosisMindfulnessUpper Motor Neuron LesionMultiple SclerosisNCT06416176Halic University30
已完成
不适用
Effect of Mindfulness-Based Stress Reduction on the fear of childbirthFear of childbirth.Fear of other medical careF40.232IRCT20171129037676N2Kerman University of Medical Sciences48
已完成
不适用
Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune HepatitisAutoimmune HepatitisNCT02950077Yale University21