Clinical trial NCT05528068: Effect of Lifestyle Intervention Among Patients With Hypertension or High-normal Blood Pressure
Official title: Effect of Lifestyle Intervention Based on Continuous Physiological Monitoring Among Patients With Hypertension or High-normal Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
High-normal Blood Pressure
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-09-06
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in peak oxygen uptake (VO2peak) from baseline to 3 months
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change in systolic blood pressure
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in diastolic blood pressure
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in cardiopulmonary exercise test-derived anaerobic threshold (AT)
timeFrame: baseline, 3 months and 9 months
measure: Change in cardiopulmonary exercise test-derived oxygen uptake efficiency slope (OUES)
timeFrame: baseline, 3 months and 9 months
measure: Change in cardiopulmonary exercise test-derived peak respiratory exchange ratio (RERpeak)
timeFrame: baseline, 3 months and 9 months
measure: Change in cardiopulmonary exercise test-derived VE/VCO2-slope
timeFrame: baseline, 3 months and 9 months
measure: Change in cardiopulmonary exercise test-derived VO2/HR
timeFrame: baseline, 3 months and 9 months
measure: Change in cardiopulmonary exercise test-derived total time of exercise
timeFrame: baseline, 3 months and 9 months
measure: Change in cardiopulmonary exercise test-derived peak metabolic equivalents (METs)
timeFrame: baseline, 3 months and 9 months
measure: Change in cardiopulmonary exercise test-derived maximal heart rate
timeFrame: baseline, 3 months and 9 months
measure: Change in concentrations of serum lipids and lipoproteins
timeFrame: baseline, 3 months and 9 months
measure: Change in concentration of fasting serum glucose
timeFrame: baseline, 3 months and 9 months
measure: Change in upper limb muscle endurance
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in lower limb muscle endurance
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in handgrip strength
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in upper and lower limbs and body flexibility
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in balance ability
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in physical activity level
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in dietary intake
timeFrame: baseline, 3 months, 6 months and 9 months
measure: Change in peak oxygen uptake (VO2peak) from baseline to 9 months
timeFrame: baseline, 9 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
name: Xue Feng, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: