Clinical trial NCT06419751: the Effects of Different Exercise on Vascular Health
Official title: Research on the Effect of Lifestyle Intervention Combined With Wearable Devices Based on Different Exercise on Vascular Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mind-body Exercise
Vascular Health
M-health
Cardiac Rehabilitation
Keywords: m-health
mind-body exercise
cardiac rehabilitation
arterial stiffness
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-05-17
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age: ≥ 18 years old and \< 60 years old;
2. cfPWV\>10m/s;
3. Those who have 1 intelligent communication device and can use it proficiently (Android mobile phone is preferred);
4. People who have lived and/or worked relatively steadily in the past 6 months;
5. Signed informed consent.

Exclusion Criteria:

1. Moderate to severe obesity (≥30kg/m\^2);
2. Acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory respiratory diseases and acute cardiovascular and cerebrovascular diseases;
3. severe essential hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg) or poorly controlled essential hypertension;
4. Patients with secondary hypertension, acute hypertension, subacute hypertension and hypertensive encephalopathy;
5. Significant arrhythmia (atrial fibrillation, etc.);
6. Patients with atherosclerotic cardiovascular diseases, such as coronary heart disease, severe peripheral atherosclerotic diseases, etc.;
7. Type 1 diabetes, uncontrolled type 2 diabetes or other diseases affecting carbohydrate metabolism;
8. 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;
9. Cancer and other major comorbidities affecting arterial blood pressure;
10. Those who are unable to exercise due to fractures, joint instability and other physical diseases or diseases affecting the locomotor system;
11. Those who have involuntary physical movements due to mental illness, epilepsy or other diseases;
12. Those who have a pacemaker installed;
13. Pregnant/trying to conceive;
14. Patients with allergies, limb trauma or skin diseases who cannot cooperate with the completion of ABI and baPWV index examinations;
15. Those who have undergone or plan to have bariatric surgery in the next 12 months;
16. Those who have participated in other clinical studies in the past 3 months;
17. Refusal to sign informed consent.

Primary outcomes:
measure: Cervical femoral pulse wave velocity（cfPWV）
timeFrame: baseline,3months,6months,9 months
Secondary outcomes:
measure: Brachi-ankle pulse wave velocity（baPWV）
timeFrame: baseline,3months,6months,9 months
measure: blood pressure
timeFrame: baseline,3months,6months,9 months
measure: body weight
timeFrame: baseline,3months,6months,9 months
measure: Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L)
timeFrame: baseline,3months,6months,9 months
measure: Physical fitness
timeFrame: baseline,3months,6months,9 months
measure: Vascular Health Index
timeFrame: baseline,3months,6months,9 months
measure: Application adherence
timeFrame: baseline,3months,6months,9 months
Other outcomes:
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xue Feng
role: PRINCIPAL_INVESTIGATOR
References: