Research on the Effect of Lifestyle Intervention Combined With Wearable Devices Based on Different Exercise on Vascular Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 主要终点
- Cervical femoral pulse wave velocity（cfPWV）
研究概览
简要总结
To explore the effect of smart app and wearable-based lifestyle intervention management on vascular health, comparing different exercise with the improvement of vascular arterial stiffness. The accuracy and consistency evaluation of smart wearable devices in screening for vascular health risks were also discussed.
详细描述
This study intends to carry out a randomized controlled trial to dynamically monitor a variety of cardiovascular parameters in people with high risk of vascular health, using wearable devices and artificial intelligence-assisted health management platform, and provide intelligent lifestyle intervention programs with different exercise.By observing the improvement of vascular health in the study population, the management effect of intelligent lifestyle intervention on high-risk groups of vascular health was evaluated. It is expected that through comprehensive lifestyle intervention based on smart wearable devices, early prevention and control of arteriosclerosis can be achieved, the level of hospital health management will be improved, and more physical health and health economic benefits will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18 years old and < 60 years old;
- •cfPWV>10m/s;
- •Those who have 1 intelligent communication device and can use it proficiently (Android mobile phone is preferred);
- •People who have lived and/or worked relatively steadily in the past 6 months;
- •Signed informed consent.
排除标准
- •Moderate to severe obesity (≥30kg/m^2);
- •Acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory respiratory diseases and acute cardiovascular and cerebrovascular diseases;
- •severe essential hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg) or poorly controlled essential hypertension;
- •Patients with secondary hypertension, acute hypertension, subacute hypertension and hypertensive encephalopathy;
- •Significant arrhythmia (atrial fibrillation, etc.);
- •Patients with atherosclerotic cardiovascular diseases, such as coronary heart disease, severe peripheral atherosclerotic diseases, etc.;
- •Type 1 diabetes, uncontrolled type 2 diabetes or other diseases affecting carbohydrate metabolism;
- •Severe stenosis of the carotid and/or femoral arteries (resulting in significant abnormalities in the blood flow spectrum); Those who have anatomical abnormalities of the aorta and major branches and cannot complete PWV detection;
- •Cancer and other major comorbidities affecting arterial blood pressure;
- •Those who are unable to exercise due to fractures, joint instability and other physical diseases or diseases affecting the locomotor system;
- •Those who have involuntary physical movements due to mental illness, epilepsy or other diseases;
- •Those who have a pacemaker installed;
- •Pregnant/trying to conceive;
- •Patients with allergies, limb trauma or skin diseases who cannot cooperate with the completion of ABI and baPWV index examinations;
- •Those who have undergone or plan to have bariatric surgery in the next 12 months;
- •Those who have participated in other clinical studies in the past 3 months;
- •Refusal to sign informed consent.
结局指标
主要结局
Cervical femoral pulse wave velocity（cfPWV）
时间窗: baseline,3months,6months,9 months
The cardio-cerebrovascular and aortic function detector (Campura, France, model: Complior Analyse) was used to measure cfPWV, and the study participants were in a supine position, lying flat on the pillow, with their palms up on their sides of the body, so that their whole body was relaxed and rested for about 3 minutes. PWV can reflect arterial stiffness, and the European Society of Cardiology recommends cfPWV \>10 m/s as the definitive threshold for assessing arterial functional changes in hypertension.We monitored cfPWV at baseline,3,6,9 months of the study.
次要结局
- Brachi-ankle pulse wave velocity（baPWV）(baseline,3months,6months,9 months)
- Physical fitness(baseline,3months,6months,9 months)
- Application adherence(baseline,3months,6months,9 months)
- blood pressure(baseline,3months,6months,9 months)
- body weight(baseline,3months,6months,9 months)
- Vascular Health Index(baseline,3months,6months,9 months)
- Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L)(baseline,3months,6months,9 months)