Elevated Blood PressureBLESSNCT05397535
Baduanjin Lower Elevated Blood PreSsure Study
A study testing Baduanjin and Brisk walking in people with Elevated Blood Pressure, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Pressure
- What is being tested?
- Baduanjin and Brisk walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2022to 11 Jul 2025
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Elevated Blood Pressure
- Being tested
- Baduanjin, Brisk walking
- Keywords
- Baduanjin, elevated blood pressure, antihypertensive effect, randomized controlled trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaduanjinBehavioural
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.
Brisk walkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-directed exercise group | No intervention | Participants in the self-directed exercise group will choose the type and duration of exercise by their preference. |
| Brisk walking group | Active comparator | Participants in Brisk Walking Group will participate in brisk walking for 52 weeks (≥5 days/week, about 30 minutes/day). Receives: Behavioral: Brisk walking |
| Baduanjin group | Experimental | Participants in Baduanjin Group will practice Baduanjin singly for 52 weeks (≥5 days/week, about 30 minutes/day). Receives: Behavioral: Baduanjin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 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.
Measured: Baseline, 12 week
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 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.
Measured: Baseline, 52 week
Secondary outcomes (14)
Other blood pressure indicators: daytime mean SBP(mmHg), nighttime mean SBP(mmHg), 24-h DBP(mmHg), daytime mean DBP(mmHg), nighttime mean DBP(mmHg)
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
Measured: Baseline,12 week,52 week
SBP(mmHg)
Blood pressure indicator:office systolic blood pressure
Measured: Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
DBP(mmHg）
Blood pressure indicator:office diastolic blood pressure
Measured: Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
FBG(mmol/L)
Glucose metabolism indicator: fasting blood glucose
Measured: Baseline,12 week,52 week
HbA1c(%)
Glucose metabolism indicator: hemoglobin A1c
Measured: Baseline,12 week,52 week
Insulin
Glucose metabolism indicator
Measured: Baseline,12 week,52 week
C-peptide
Glucose metabolism indicator
Measured: Baseline,12 week,52 week
Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L)
Lipid metabolism indicators: total cholesterol , triglyceride , high density lipoprotein cholesterol, low density lipoprotein cholesterol
Measured: Baseline,12 week,52 week
Total scores of The Short-Form-36 Health Survey (SF-36)
The total scores range from 0-100, and the higher scores mean better outcomes
Measured: Baseline,12 week,52 week
Total scores of Pittsburgh Sleep Quality Index(PSQI)
The total scores range from 0-21, and the higher scores mean worse outcomes
Measured: Baseline,12 week,52 week
Total scores of Generalized Anxiety Disorder-7(GAD-7)
The total scores range from 0-21, and the higher scores mean worse outcomes
Measured: Baseline,12 week,52 week
Total scores of Patient Health Questionnaire-9 items(PHQ-9)
The total scores range from 0-27 , and the higher scores mean worse outcomes
Measured: Baseline,12 week,52 week
Total scores of Neck Disability Index(NDI)
The total scores range from 0-100%, and the higher scores mean worse outcomes
Measured: Baseline,12 week,52 week
Sit and reach test(cm)
Motor system function: sit and reach test
Measured: Baseline,12 week,52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start5 Jun 2022
- Primary completion4 Jul 2024
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated Blood PressureStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jing Li, MD,PhD, Principal investigator, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397535
- Sponsor's protocol ID
- 2022-1724
- Acronym
- BLESS
- Status last verified
- Sep 2025
- First submitted
- 20 May 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pu B, Zhang L, Sun Y, Yu Y, Yan L, Li Y, Liu J, Zheng X, Zhang H, Peng Y, Wang Y, Zhao Y, Ma X, Guo L, Wang Z, Li G, Wang Z, Liu P, Yang Y, Shao L, Yan X, Zhen J, Li D, Guo J, Ding H, Ma Y, Bai W, Hu R, Li J. Effect of Baduanjin on Blood Pressure Among Individuals With High-Normal Blood Pressure: A Multicenter, Open-Label, Blinded-Outcome Randomized Controlled Trial. J Am Coll Cardiol. 2026 Feb 18:S0735-1097(26)00077-X. doi: 10.1016/j.jacc.2026.01.014. Online ahead of print.
PubMed 41706075
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Exercise as Convenient Approach to Improve Health 1-Baduanjin Lower Elevated Blood PreSsure Study
- ClinicalTrials.gov ID
- NCT05397535
- Acronym / sponsor ID
- BLESS / 2022-1724
- Conditions
- Elevated Blood Pressure
- Keywords
- Baduanjin, elevated blood pressure, antihypertensive effect, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 31 May 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-directed exercise group | No intervention | –Participants in the self-directed exercise group will choose the type and duration of exercise by their preference. |
| Brisk walking group | Active comparator | Behavioral: Brisk walkingParticipants in Brisk Walking Group will participate in brisk walking for 52 weeks (≥5 days/week, about 30 minutes/day). |
| Baduanjin group | Experimental | Behavioral: BaduanjinParticipants in Baduanjin Group will practice Baduanjin singly for 52 weeks (≥5 days/week, about 30 minutes/day). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| BaduanjinParticipants 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. | Behavioural | Baduanjin group |
| Brisk walkingParticipants 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. | Behavioural | Brisk walking group |
Primary outcome
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.
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.
14 secondary outcomes
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
SBP(mmHg)
Time frame: 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
FBG(mmol/L)
Time frame: Baseline,12 week,52 week
HbA1c(%)
Time frame: Baseline,12 week,52 week
Insulin
Time frame: Baseline,12 week,52 week
C-peptide
Time frame: 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
Total scores of The Short-Form-36 Health Survey (SF-36)
Time frame: Baseline,12 week,52 week
Total scores of Pittsburgh Sleep Quality Index(PSQI)
Time frame: Baseline,12 week,52 week
Total scores of Generalized Anxiety Disorder-7(GAD-7)
Time frame: Baseline,12 week,52 week
Total scores of Patient Health Questionnaire-9 items(PHQ-9)
Time frame: Baseline,12 week,52 week
Total scores of Neck Disability Index(NDI)
Time frame: Baseline,12 week,52 week
Sit and reach test(cm)
Time frame: Baseline,12 week,52 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 41706075Pu B, Zhang L, Sun Y, Yu Y, Yan L, Li Y, Liu J, Zheng X, Zhang H, Peng Y, Wang Y, Zhao Y, Ma X, Guo L, Wang Z, Li G, Wang Z, Liu P, Yang Y, Shao L, Yan X, Zhen J, Li D, Guo J, Ding H, Ma Y, Bai W, Hu R, Li J. Effect of Baduanjin on Blood Pressure Among Individuals With High-Normal Blood Pressure: A Multicenter, Open-Label, Blinded-Outcome Randomized Controlled Trial. J Am Coll Cardiol. 2026 Feb 18:S0735-1097(26)00077-X. doi: 10.1016/j.jacc.2026.01.014. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Jing Li, MD,PhD principal investigator
National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin and Brisk walking in people with Elevated 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 15 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: finished, as of the sponsor's last update on 10 Sep 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 12 week (time frame: Baseline, 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397535, which also lists 1 linked publication.
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 10 Sep 2025.