Effect of Lifestyle Intervention Based on Continuous Physiological Monitoring Among Patients With Hypertension or High-normal Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Change in peak oxygen uptake (VO2peak) from baseline to 3 months
研究概览
简要总结
Hypertension is a major risk factor for cardiovascular disease and cardiovascular events. Healthy lifestyle factors are widely recommended for hypertension prevention and control, and cardiorespiratory fitness is a strong and independent predictor of the progression of hypertension. Increased cardiorespiratory fitness through lifestyle modifications is associated with lower mortality in hypertensive or high-normal blood pressure individuals. The aim of the study is to evaluate the effects of supervised lifestyle intervention that include diet and exercise and base on intelligent application and continuous physiological monitoring on improvement of cardiopulmonary fitness, blood pressure and other health outcomes among participants with hypertension or high-normal blood pressure.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who is ≥18 years old and < 70 years old;
- •hypertension or high-normal blood pressure;
- •who has a smart phone and can use it (android phones are preferred).
排除标准
- •with acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory diseases or respiratory diseases;
- •with acute cardiovascular and cerebrovascular diseases;
- •poor blood pressure control;
- •with physical limitations(e.g., restricting injuries of the musculoskeletal system, such as fractures, unstable joints and other physical diseases);
- •with skin disease or skin damage at the site of wearable device;
- •with mental disorder, epilepsy or other diseases resulting in inability to control the body;
- •pacemaker installation;
- •woman who is during pregnancy or prepare for pregnancy;
- •sensitive skin for wearable devices; 10）refuse to provide written informed consent.
结局指标
主要结局
Change in peak oxygen uptake (VO2peak) from baseline to 3 months
时间窗: baseline, 3 months
VO2peak is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months.
次要结局
- Change in upper limb muscle endurance(baseline, 3 months, 6 months and 9 months)
- Change in cardiopulmonary exercise test-derived total time of exercise(baseline, 3 months and 9 months)
- Change in cardiopulmonary exercise test-derived peak metabolic equivalents (METs)(baseline, 3 months and 9 months)
- Change in concentrations of serum lipids and lipoproteins(baseline, 3 months and 9 months)
- Change in cardiopulmonary exercise test-derived anaerobic threshold (AT)(baseline, 3 months and 9 months)
- Change in cardiopulmonary exercise test-derived VE/VCO2-slope(baseline, 3 months and 9 months)
- Change in cardiopulmonary exercise test-derived maximal heart rate(baseline, 3 months and 9 months)
- Change in lower limb muscle endurance(baseline, 3 months, 6 months and 9 months)
- Change in systolic blood pressure(baseline, 3 months, 6 months and 9 months)
- Change in cardiopulmonary exercise test-derived peak respiratory exchange ratio (RERpeak)(baseline, 3 months and 9 months)
- Change in cardiopulmonary exercise test-derived VO2/HR(baseline, 3 months and 9 months)
- Change in concentration of fasting serum glucose(baseline, 3 months and 9 months)
- Change in peak oxygen uptake (VO2peak) from baseline to 9 months(baseline, 9 months)
- Change in diastolic blood pressure(baseline, 3 months, 6 months and 9 months)
- Change in cardiopulmonary exercise test-derived oxygen uptake efficiency slope (OUES)(baseline, 3 months and 9 months)
- Change in physical activity level(baseline, 3 months, 6 months and 9 months)
- Change in handgrip strength(baseline, 3 months, 6 months and 9 months)
- Change in upper and lower limbs and body flexibility(baseline, 3 months, 6 months and 9 months)
- Change in balance ability(baseline, 3 months, 6 months and 9 months)
- Change in dietary intake(baseline, 3 months, 6 months and 9 months)
研究者
Xue Feng
Executive Deputy Director
China National Center for Cardiovascular Diseases