Effect of Lifestyle Intervention Among Patients With Hypertension or High-normal Blood Pressure

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Hypertension; High-normal Blood Pressure

Treatments: Behavioral: supervised lifestyle intervention; Behavioral: healthy lifestyle education

Study type: Interventional

Funder types: Other

Identifiers

NCT05528068

2021-1559

Details and patient eligibility

About

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.

Enrollment: 424 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. who is ≥18 years old and < 70 years old;
2. hypertension or high-normal blood pressure;
3. who has a smart phone and can use it (android phones are preferred).

Exclusion criteria

1. with acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory diseases or respiratory diseases;
2. with acute cardiovascular and cerebrovascular diseases;
3. poor blood pressure control;
4. with physical limitations(e.g., restricting injuries of the musculoskeletal system, such as fractures, unstable joints and other physical diseases);
5. with skin disease or skin damage at the site of wearable device;
6. with mental disorder, epilepsy or other diseases resulting in inability to control the body;
7. pacemaker installation;
8. woman who is during pregnancy or prepare for pregnancy;
9. sensitive skin for wearable devices; 10）refuse to provide written informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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424 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

standard care, physiological monitoring by wearable devices and healthy lifestyle education

Treatment:

Behavioral: healthy lifestyle education

supervised lifestyle intervention group

Experimental group

Description:

standard care, physiological monitoring by wearable devices and personalized and supervised lifestyle intervention including dietary and physical activity modification

Treatment:

Behavioral: supervised lifestyle intervention