Personal Activity Intelligence (PAI) in the Treatment of High Blood Pressure: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 24 hour blood pressure
研究概览
简要总结
Personal Activity Intelligence (PAI) is a novel metric developed to quantify the amount of routine physical activity (PA) needed to improve health and reduce cardiovascular (CV) mortality. The PAI metric can be integrated in PA monitors to promote and track PA. The present pilot study is a 12-week randomized controlled trial designed to test the efficacy of PAI in the treatment of high blood pressure. The primary aim is to investigate how routine PA (expressed as PAI level) affect ambulatory blood pressure by comparing the effect of the intervention (≥100 PAI per week) with a control recommended to follow national PA guidelines. The secondary aims are to investigate the effect on a comprehensive CV risk profile, and to model the effect of PAI level on multiple CV parameters. The CV risk profile includes office BP, arterial stiffness, stroke volume, heart rate, cardiac output, systemic vascular resistance, cardiorespiratory fitness, body composition, blood lipid profile and serum markers of glucose metabolism, kidney failure and systemic inflammation.
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
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systolic blood pressure (SBP) 130-179 mmHg and/or diastolic blood pressure (DBP) 80-109 mmHg at first clinical visit (screening). Note, this criteria was updated after the inclusion of three participants. The initial inclusion criteria were SBP 140-179 mmHg and/or DBP 90-109 mmHg.
- •Not currently engaged in regular physical activity (< 50 PAI per week based on self-reported PA)
排除标准
- •Usage of blood pressure medication
- •Usage of lipid modifying agents
- •Cardiovascular disease
- •Diagnosed secondary hypertension
- •Disease or disability that prevent exercise or participation in testing
结局指标
主要结局
24 hour blood pressure
时间窗: Pre- to postintervention (12 weeks)
Change in average systolic and diastolic blood pressure over 24 hours (mmHg). 24h blood pressure is measured automatically 2-3 times per hour with an oscillometric ambulatory blood pressure monitor.
次要结局
- Office blood pressure(Pre- to postintervention (12 weeks))
- Arterial stiffness(Pre- to postintervention (12 weeks))
- Cardiac function(Pre- to postintervention (12 weeks))
- Cardiorespiratory fitness(Pre- to postintervention (12 weeks))