Baduanjin Lower Elevated Blood PreSsure Study (BLESS)

September 3, 2025 updated by: China National Center for Cardiovascular Diseases

Traditional Exercise as Convenient Approach to Improve Health 1-Baduanjin Lower Elevated Blood PreSsure Study

The aim of this study is to evaluate the effects of Baduanjin on blood pressure in individuals with high normal blood pressure (SBP 130-139 mmHg, and/or DBP 85-89 mmHg), as well as on glucose and lipid metabolism, quality of life, psychology, exercise, immune inflammation, endothelial function, and arterial stiffness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 40 years or older;
  • Systolic blood pressure (SBP) <140 mmHg and diastolic blood pressure (DBP) <90 mmHg
  • SBP 130-139 mmHg, and/or DBP 85-89 mmHg

Exclusion Criteria:

  • Diagnosis of hypertension (SBP≥140 mmHg, and/or DBP ≥90mmHg）
  • History of cardiovascular diseases, such as coronary heart disease, heart failure, stroke, and peripheral vascular disease
  • Diagnosis of chronic kidney disease, primary aldosteronism, Cushing's syndrome, or pheochromocytoma
  • Newly diagnosed cancer or cancer metastasis within 5 years
  • History of autoimmune disease
  • Having taken antihypertensive drugs or immunoregulators within 2 weeks
  • A long-term need for antihypertensive drugs or immunomoregulators
  • Unable to maintain moderate intensity exercise due to illness or other reasons
  • Pregnant, breastfeeding, or planning to become pregnant within the next 1 year
  • Currently taking regular exercise (at least 30 minutes of moderate-intensity exercise at least three times a week)
  • Allergic to sports bracelets
  • Having participated or been participating in other clinical trials within the last 3 months
  • Unable to use smartphones
  • Other factors that may affect the follow-up, such as alcohol or substance abuse in the last 12 months, planing to live out of town for a long time, or diagnosis of dementia or cognitive impairment which indicates incapability of completing the study
  • Unable to accurately measure blood pressure using the sphygmomanometer provided by the study due to a too large or too small arm circumference

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Self-directed exercise group
Participants in the self-directed exercise group will choose the type and duration of exercise by their preference.
Active Comparator: Brisk walking group
Participants in Brisk Walking Group will participate in brisk walking for 52 weeks (≥5 days/week, about 30 minutes/day).
Behavioral: Brisk walking
Participants in this group will receive health education on hypertension and practice brisk walking on their own for at least 30 minutes, at least 5 days per week for 52 weeks. These participants will be required to do brisk walking regularly, and the researcher will monitor their adherence to practice and provide reminders if needed.
Experimental: Baduanjin group
Participants in Baduanjin Group will practice Baduanjin singly for 52 weeks (≥5 days/week, about 30 minutes/day).
Behavioral: Baduanjin
Participants in Baduanjin group will receive health education on hypertension and attend a 4-hour class to learn Baduanjin before receiving the interventions after the randomization. Baduanjin exercise protocol is based on the "Fitness Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003. Each Badaunjin exercise session will last at least 30 minutes and be conducted at least 5 days per week for 52 weeks. These participants will be required to practice Baduanjin regularly, and the researchers will monitor their adherence to practice and provide reminders if needed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 12 week
Time Frame: Baseline, 12 week
Change form Baseline ambulatory 24-h systolic blood pressure at 12 week will be measured by ambulatory blood pressure monitoring to investigate the short-term antihypertensive effect of Baduanjin.
Baseline, 12 week
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 52 week
Time Frame: Baseline, 52 week
Change from baseline ambulatory 24-h systolic blood pressure at 52 week will be measured by ambulatory blood pressure monitoring to investigate the long-term antihypertensive effect of Baduanjin.
Baseline, 52 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other blood pressure indicators: daytime mean SBP(mmHg), nighttime mean SBP(mmHg), 24-h DBP(mmHg), daytime mean DBP(mmHg), nighttime mean DBP(mmHg)
Time Frame: Baseline,12 week,52 week
Other blood pressure indicators:daytime mean systolic blood pressure, nighttime mean systolic blood pressure, 24-h diastolic blood pressure, daytime mean diastolic blood pressure, nighttime mean diastolic blood pressure
Baseline,12 week,52 week
SBP(mmHg)
Time Frame: Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
Blood pressure indicator:office systolic blood pressure
Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
DBP(mmHg）
Time Frame: Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
Blood pressure indicator:office diastolic blood pressure
Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
FBG(mmol/L)
Time Frame: Baseline,12 week,52 week
Glucose metabolism indicator: fasting blood glucose
Baseline,12 week,52 week
HbA1c(%)
Time Frame: Baseline,12 week,52 week
Glucose metabolism indicator: hemoglobin A1c
Baseline,12 week,52 week
Insulin
Time Frame: Baseline,12 week,52 week
Glucose metabolism indicator
Baseline,12 week,52 week
C-peptide
Time Frame: Baseline,12 week,52 week
Glucose metabolism indicator
Baseline,12 week,52 week
Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L)
Time Frame: Baseline,12 week,52 week
Lipid metabolism indicators: total cholesterol , triglyceride , high density lipoprotein cholesterol, low density lipoprotein cholesterol
Baseline,12 week,52 week
Total scores of The Short-Form-36 Health Survey (SF-36)
Time Frame: Baseline,12 week,52 week
The total scores range from 0-100, and the higher scores mean better outcomes
Baseline,12 week,52 week
Total scores of Pittsburgh Sleep Quality Index(PSQI)
Time Frame: Baseline,12 week,52 week
The total scores range from 0-21, and the higher scores mean worse outcomes
Baseline,12 week,52 week
Total scores of Generalized Anxiety Disorder-7(GAD-7)
Time Frame: Baseline,12 week,52 week
The total scores range from 0-21, and the higher scores mean worse outcomes
Baseline,12 week,52 week
Total scores of Patient Health Questionnaire-9 items(PHQ-9)
Time Frame: Baseline,12 week,52 week
The total scores range from 0-27 , and the higher scores mean worse outcomes
Baseline,12 week,52 week
Total scores of Neck Disability Index(NDI)
Time Frame: Baseline,12 week,52 week
The total scores range from 0-100%, and the higher scores mean worse outcomes
Baseline,12 week,52 week
Sit and reach test(cm)
Time Frame: Baseline,12 week,52 week
Motor system function: sit and reach test
Baseline,12 week,52 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
hs-CRP(mg/L)
Time Frame: Baseline,12 week,52 week
Inflammatory indicator:high-sensitivity C-reactive protein
Baseline,12 week,52 week
IL-1β(pg/mL)
Time Frame: Baseline,12 week,52 week
Inflammatory indicator:interleukin-1β
Baseline,12 week,52 week
TNF-α(pg/mL)
Time Frame: Baseline,12 week,52 week
Inflammatory indicator:tumor necrosis factor-α
Baseline,12 week,52 week
FMD(%)
Time Frame: Baseline,12 week,52 week
Endothelial function indicator:flow mediated dilatation
Baseline,12 week,52 week
NO(μmol/mL)
Time Frame: Baseline,12 week,52 week
Endothelial function indicator:nitric oxides
Baseline,12 week,52 week
PG(pg/mL)
Time Frame: Baseline,12 week,52 week
Endothelial function indicator:prostaglandin
Baseline,12 week,52 week
cfPWV(m/s)
Time Frame: Baseline,12 week,52 week
Atherosclerosis:carotid-femoral pulse wave velocity
Baseline,12 week,52 week
Whole genome gene expression profiling in peripheral blood mononuclear cells
Time Frame: Baseline,12 week,52 week
Immunological indicator
Baseline,12 week,52 week
Thymic volume(cm^3)
Time Frame: Baseline,52 week
Immunological indicator
Baseline,52 week
BMI(kg/m^2)
Time Frame: Baseline,12 week,52 week
Anthropometric indicator:Body mass index
Baseline,12 week,52 week
Waist circumference(cm)
Time Frame: Baseline,12 week,52 week
Anthropometric indicator
Baseline,12 week,52 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing Li, MD,PhD, National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-1724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings