Assessing Alternative Approaches for Blood Pressure Control: A3BC Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Blood Pressure
研究概览
简要总结
An estimated 76 million adults in the United States over the age of 20 have hypertension (HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25% for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the population together with increases in obesity and sedentary behavior, it is not surprising that HTN is projected to increase significantly over the next several decades; with over 1.5 billion adults having HTN by the year 2025. Thus the public health implications to preventing and/or reducing elevations in blood pressure are substantial.
This study compares the efficacy of two different non-pharmacologic interventions (device guided breathing and isometric hand grip exercises) used alone and in combination for lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension. The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the interventions by participants. The knowledge gained from this study can provide information on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge may be especially useful for patients for whom access to medications and health care is limited and among patients unwilling to take or intolerant to pharmacologic therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 21 years old, and
- •Have Stage 1 high blood pressure. (Defined as a systolic blood pressure between 140 mm Hg and 159 mm Hg (the top blood pressure number) and/or a diastolic blood pressure between 90 mm Hg and 99 mm Hg (the bottom blood pressure number) in the prior 6 months.)
排除标准
- •Take drugs to control blood pressure.
- •Have a history of left ventricular hypertrophy.
- •Have a history of cardiovascular disease such as stroke, mini-strokes, heart attack, unstable angina, bypass surgery, stents, angioplasty, abnormal heart rhythms, heart failure, or peripheral artery disease.
- •Have diabetes.
- •Have a history of poor kidney function.
- •Have an upper arm circumference greater than 17 inches.
- •Are currently participating in a formal exercise or weight loss program.
- •Plan to participate in a formal exercise or weight loss program in the next 6 months.
- •Are pregnant or plan to become pregnant in the next 6 months.
研究组 & 干预措施
Device Guided Breathing/Combination Therapy
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises. Participants will be given a home blood pressure monitor. Participants will measure blood pressure and heart rate at home for 2 weeks prior to starting any intervention and also during the 16 week of intervention.
干预措施: Device guided breathing RESPeRATE (Device)
Device Guided Breathing/Combination Therapy
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises. Participants will be given a home blood pressure monitor. Participants will measure blood pressure and heart rate at home for 2 weeks prior to starting any intervention and also during the 16 week of intervention.
干预措施: Isometric hand grip Zona Plus (Device)
Isometric Hand Grip/Combination Therapy
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises. Participants will be given a home blood pressure monitor. Participants will measure blood pressure and heart rate at home for 2 weeks prior to starting any intervention and also during the 16 week of intervention.
干预措施: Device guided breathing RESPeRATE (Device)
Isometric Hand Grip/Combination Therapy
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises. Participants will be given a home blood pressure monitor. Participants will measure blood pressure and heart rate at home for 2 weeks prior to starting any intervention and also during the 16 week of intervention.
干预措施: Isometric hand grip Zona Plus (Device)
结局指标
主要结局
Change in Blood Pressure
时间窗: 8 weeks and 16 weeks
Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.
次要结局
- Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)(8 weeks)
- Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)(8 weeks)
研究者
Elizabeth A. Jackson
Associate Professor
University of Michigan