HypertensionNCT05528068
Effect of Lifestyle Intervention Among Patients With Hypertension or High-normal Blood Pressure
A study testing supervised lifestyle intervention and healthy lifestyle education in people with Hypertension and High-normal Blood Pressure, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, High-normal Blood Pressure
- What is being tested?
- supervised lifestyle intervention and healthy lifestyle education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2022to 27 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- pacemaker installation;
- woman who is during pregnancy or prepare for pregnancy;
- sensitive skin for wearable devices; 10）refuse to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Xue Feng, MD PhD, +86-15601378512, 29611290@qq.com
About this study
Official title: Effect of Lifestyle Intervention Based on Continuous Physiological Monitoring Among Patients With Hypertension or High-normal Blood Pressure
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.
- Conditions
- Hypertension, High-normal Blood Pressure
- Being tested
- supervised lifestyle intervention, healthy lifestyle education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised lifestyle interventionBehavioural
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.
healthy lifestyle educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | standard care, physiological monitoring by wearable devices and healthy lifestyle education Receives: Behavioral: healthy lifestyle education |
| supervised lifestyle intervention group | Experimental | standard care, physiological monitoring by wearable devices and personalized and supervised lifestyle intervention including dietary and physical activity modification Receives: Behavioral: supervised lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months
Secondary outcomes (20)
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months and 9 months
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 3 months, 6 months and 9 months
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.
Measured: baseline, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start27 Jul 2022
- Primary completion27 Apr 2023 (estimated)
- Study completion27 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xue Feng, China National Center for Cardiovascular Diseases
- Investigators
- Xue Feng, MD PhD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528068
- Sponsor's protocol ID
- 2021-1559
- Status last verified
- Sep 2022
- First submitted
- 25 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to contact the researcher for sharing after the trial
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyle Intervention Based on Continuous Physiological Monitoring Among Patients With Hypertension or High-normal Blood Pressure
- ClinicalTrials.gov ID
- NCT05528068
- Acronym / sponsor ID
- 2021-1559
- Conditions
- Hypertension, High-normal Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 27 Apr 2023 (estimated)
- Study completion
- 27 Oct 2023 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Behavioral: healthy lifestyle educationstandard care, physiological monitoring by wearable devices and healthy lifestyle education |
| supervised lifestyle intervention group | Experimental | Behavioral: supervised lifestyle interventionstandard care, physiological monitoring by wearable devices and personalized and supervised lifestyle intervention including dietary and physical activity modification |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supervised lifestyle interventionParticipants 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. | Behavioural | supervised lifestyle intervention group |
| healthy lifestyle educationParticipants 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. | Behavioural | control group |
Primary outcome
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.
20 secondary outcomes
Change in systolic blood pressure
Time frame: baseline, 3 months, 6 months and 9 months
Change in diastolic blood pressure
Time frame: baseline, 3 months, 6 months and 9 months
Change in cardiopulmonary exercise test-derived anaerobic threshold (AT)
Time frame: baseline, 3 months and 9 months
Change in cardiopulmonary exercise test-derived oxygen uptake efficiency slope (OUES)
Time frame: baseline, 3 months and 9 months
Change in cardiopulmonary exercise test-derived peak respiratory exchange ratio (RERpeak)
Time frame: baseline, 3 months and 9 months
Change in cardiopulmonary exercise test-derived VE/VCO2-slope
Time frame: baseline, 3 months and 9 months
Change in cardiopulmonary exercise test-derived VO2/HR
Time frame: baseline, 3 months and 9 months
Change in cardiopulmonary exercise test-derived total time of exercise
Time frame: baseline, 3 months and 9 months
Change in cardiopulmonary exercise test-derived peak metabolic equivalents (METs)
Time frame: baseline, 3 months and 9 months
Change in cardiopulmonary exercise test-derived maximal heart rate
Time frame: baseline, 3 months and 9 months
Change in concentrations of serum lipids and lipoproteins
Time frame: baseline, 3 months and 9 months
Change in concentration of fasting serum glucose
Time frame: baseline, 3 months and 9 months
Change in upper limb muscle endurance
Time frame: baseline, 3 months, 6 months and 9 months
Change in lower limb muscle endurance
Time frame: baseline, 3 months, 6 months and 9 months
Change in handgrip strength
Time frame: baseline, 3 months, 6 months and 9 months
Change in upper and lower limbs and body flexibility
Time frame: baseline, 3 months, 6 months and 9 months
Change in balance ability
Time frame: baseline, 3 months, 6 months and 9 months
Change in physical activity level
Time frame: baseline, 3 months, 6 months and 9 months
Change in dietary intake
Time frame: baseline, 3 months, 6 months and 9 months
Change in peak oxygen uptake (VO2peak) from baseline to 9 months
Time frame: baseline, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: No. to contact the researcher for sharing after the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xue Feng, MD PhD principal investigator
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised lifestyle intervention and healthy lifestyle education in people with Hypertension and High-normal Blood Pressure, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongyi Du, MD PhD (86-10-88396087, duhy@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (VO2peak) from baseline to 3 months (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.