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

Not Applicable

Recruiting

• Conditions: High-normal Blood Pressure; Hypertension
• Interventions: Behavioral: healthy lifestyle education; Behavioral: supervised lifestyle intervention

• Registration Number: NCT05528068
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-27
• Study First Submitted: 2022-08-25
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Primary Completion: 2023-04-27
• Study Completion: 2023-10-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 424

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	healthy lifestyle education	standard care, physiological monitoring by wearable devices and healthy lifestyle education
supervised lifestyle intervention group	supervised lifestyle intervention	standard care, physiological monitoring by wearable devices and personalized and supervised lifestyle intervention including dietary and physical activity modification

Primary Outcome Measures

Name	Time	Method
Change in peak oxygen uptake (VO2peak) from baseline to 3 months	baseline, 3 months	VO2peak is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months.

Secondary Outcome Measures

Name	Time	Method
Change in upper limb muscle endurance	baseline, 3 months, 6 months and 9 months	The subject stands holding dumbbells (8 pounds for men, 5 pounds for women) with arms straight and hanging down next to the body. After the start, the subject will bend his arms to the shoulders and calculate 30 seconds. The total number of correct bends in 30 second. Change from baseline to 3 months, 6 months and 9 months will be measured.
Change in cardiopulmonary exercise test-derived total time of exercise	baseline, 3 months and 9 months	Total time of exercise is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in cardiopulmonary exercise test-derived peak metabolic equivalents (METs)	baseline, 3 months and 9 months	Peak METs is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in concentrations of serum lipids and lipoproteins	baseline, 3 months and 9 months	Concentrations of serum lipids and lipoproteins, including low-density lipoprotein-cholesterol, total cholesterol, triglycerides, and high-density lipoprotein-cholesterol, are obtained from blood laboratory data, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in cardiopulmonary exercise test-derived anaerobic threshold (AT)	baseline, 3 months and 9 months	AT is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in cardiopulmonary exercise test-derived VE/VCO2-slope	baseline, 3 months and 9 months	VE/VCO2-slope is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in cardiopulmonary exercise test-derived maximal heart rate	baseline, 3 months and 9 months	Maximal heart rate is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in lower limb muscle endurance	baseline, 3 months, 6 months and 9 months	The subject sits in the middle of the chair with his back straight, hands crossed in front of his chest, after the start, the subject stands up and sits down, and counts the number of standing up and sitting times completed within 30 seconds. Change from baseline to 3 months, 6 months and 9 months will be measured.
Change in systolic blood pressure	baseline, 3 months, 6 months and 9 months	Systolic blood pressure is measured at baseline, 3 months, 6 months and 9 months. Change from baseline to 3 months, 6 months and 9 months will be measured.
Change in cardiopulmonary exercise test-derived peak respiratory exchange ratio (RERpeak)	baseline, 3 months and 9 months	RERpeak is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in cardiopulmonary exercise test-derived VO2/HR	baseline, 3 months and 9 months	VO2/HR is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in concentration of fasting serum glucose	baseline, 3 months and 9 months	Concentration of fasting serum glucose is obtained from blood laboratory data, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in peak oxygen uptake (VO2peak) from baseline to 9 months	baseline, 9 months	VO2peak is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline and 9 months.
Change in diastolic blood pressure	baseline, 3 months, 6 months and 9 months	Diastolic blood pressure is measured at baseline, 3 months, 6 months and 9 months. Change from baseline to 3 months, 6 months and 9 months will be measured.
Change in cardiopulmonary exercise test-derived oxygen uptake efficiency slope (OUES)	baseline, 3 months and 9 months	OUES is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months and 9 months. Change from baseline to 3 months and 9 months will be measured.
Change in physical activity level	baseline, 3 months, 6 months and 9 months	Average physical activity level is measured at baseline, 3 months, 6 months and 9 months by International Physical Activity Questionnaire (IPAQ). Daily physical activity level is recorded by worn smart watch. Change from baseline to 3 months, 6months and 9 months will be measured.
Change in handgrip strength	baseline, 3 months, 6 months and 9 months	Adjust the grip bar so the second joint of the fingers fits snugly under the handle and takes the weight of the instrument. Set the dynamometer to zero. The subject holds the handgrip dynamometer in line with the forearm at the level of the thigh, away from the body. The subject squeezes the handgrip dynamometer as hard as possible without holding the breath. Neither the hand nor the handgrip dynamometer should touch the body or any other object. Repeat the test twice with each hand. The score is the highest of the two readings for each hand. Change from baseline to 3 months, 6 months and 9 months will be measured.
Change in upper and lower limbs and body flexibility	baseline, 3 months, 6 months and 9 months	The subject adopts a standing posture, with the dominant hand placed behind the shoulder on the same side, with the palm facing the back, with the fingers straight, stretch down as far as possible along the center of the back, and the palm of the other hand outwards from the bottom Extend your back upwards, keep your hands as close as possible, touch each other, or overlap your hands. Never hold and pull with your hands. Measure the distance between the middle finger of both hands.; The subject sits on the front edge of the chair, with one foot bent on the ground, the other foot is straight forward, the heel touches the ground, the toes are raised, and the palms of both hands are folded (middle fingers) and stretched out. Stretch straight feet. Measure the distance from the middle finger to the toe.; Change from baseline to 3 months, 6 months and 9 months will be measured.
Change in balance ability	baseline, 3 months, 6 months and 9 months	Stand with your hands on your waist, stand on one foot, and place the foot off the ground on the inside of the ankle that supports your foot. Record the right and left foot support time for correct actions, with a full score of 30 seconds.; Change from baseline to 3 months, 6 months and 9 months will be measured.
Change in dietary intake	baseline, 3 months, 6 months and 9 months	Dietary intake is measured at baseline, 3 months, 6 months and 9 months by 24-hour dietary recalls for 3 days. Change from baseline to 3 months, 6months and 9 months will be measured.

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China