Effect of Lifestyle Intervention Based on Continuous Physiological Monitoring Among Patients With Hypertension or High-normal Blood Pressure

China National Center for Cardiovascular Diseases1 site in 1 country424 target enrollmentJuly 27, 2022

ConditionsHypertension High-normal Blood Pressure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: China National Center for Cardiovascular Diseases
Enrollment: 424
Locations: 1
Primary Endpoint: Change in peak oxygen uptake (VO2peak) from baseline to 3 months
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 27, 2022

End Date

October 27, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China National Center for Cardiovascular Diseases

Responsible Party

Principal Investigator

Xue Feng

Executive Deputy Director

China National Center for Cardiovascular Diseases

Eligibility Criteria

Inclusion Criteria

•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).

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Change in peak oxygen uptake (VO2peak) from baseline to 3 months

Time Frame: baseline, 3 months

VO2peak is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months.

Secondary Outcomes

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)