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

Primary Purpose

Hypertension, High-normal Blood Pressure

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

supervised lifestyle intervention

healthy lifestyle education

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

supervised lifestyle intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in peak oxygen uptake (VO2peak) from baseline to 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

Change in systolic blood pressure

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 diastolic blood pressure

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 anaerobic threshold (AT)

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 oxygen uptake efficiency slope (OUES)

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 cardiopulmonary exercise test-derived peak respiratory exchange ratio (RERpeak)

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 VE/VCO2-slope

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 VO2/HR

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 cardiopulmonary exercise test-derived total time of exercise

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)

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 cardiopulmonary exercise test-derived maximal heart rate

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 concentrations of serum lipids and lipoproteins

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 concentration of fasting serum glucose

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 upper limb muscle endurance

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 lower limb muscle endurance

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 handgrip strength

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

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

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 physical activity level

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 dietary intake

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.

Change in peak oxygen uptake (VO2peak) from baseline to 9 months

VO2peak is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline and 9 months.

Full Information

NCT ID

NCT05528068

First Posted

August 25, 2022

Last Updated

September 2, 2022

Sponsor

China National Center for Cardiovascular Diseases

1. Study Identification

Unique Protocol Identification Number

NCT05528068

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 27, 2022 (Actual)

Primary Completion Date

April 27, 2023 (Anticipated)

Study Completion Date

October 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, High-normal Blood Pressure

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

424 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

supervised lifestyle intervention group

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

supervised lifestyle intervention

Intervention Description

Participants will receive personalized dietary and exercise prescription according to the assessment of nutritional status, physical fitness and physiological-biochemical indexes. The participants will use the digital application for the first 3 months with supervised lifestyle intervention. Wearable devices, such as ambulatory blood pressure monitoring, dynamic electrocardio scanner and smart watch, will be worn to provide continuous physiological monitoring for safety. And then, participants will use the application by self-management for the next 6 months. All participants are given questionnaires, nutritional, physical fitness and physiological-biochemical assessment at baseline, 3 months, 6 months and 9 months.

Intervention Type

Behavioral

Intervention Name(s)

healthy lifestyle education

Intervention Description

Participants will receive standard care and healthy lifestyle education for hypertension prevention and control. Wearable devices, such as ambulatory blood pressure monitoring, dynamic electrocardio scanner and smart watch, will be worn to provide continuous physiological monitoring for safety. Participants will use the application by self-management for 9 months. All participants are given questionnaires, nutritional, physical fitness and physiological-biochemical assessment at baseline, 3 months, 6 months and 9 months.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

baseline, 3 months

Secondary Outcome Measure Information:

Title

Change in systolic blood pressure

Description

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.

Time Frame

baseline, 3 months, 6 months and 9 months

Title

Change in diastolic blood pressure

Description

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.

Time Frame

baseline, 3 months, 6 months and 9 months

Title

Change in cardiopulmonary exercise test-derived anaerobic threshold (AT)

Description

Time Frame