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Completed

NCT Number: NCT05397535

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.

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Key information

Conditions

Elevated Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baduanjin

Behavioral

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 walking

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. SBP(mmHg)

    Time frame: Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week

    Blood pressure indicator:office systolic blood pressure

  3. DBP(mmHg）

    Time frame: Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week

    Blood pressure indicator:office diastolic blood pressure

  4. FBG(mmol/L)

    Time frame: Baseline,12 week,52 week

    Glucose metabolism indicator: fasting blood glucose

  5. HbA1c(%)

    Time frame: Baseline,12 week,52 week

    Glucose metabolism indicator: hemoglobin A1c

  6. Insulin

    Time frame: Baseline,12 week,52 week

    Glucose metabolism indicator

  7. C-peptide

    Time frame: Baseline,12 week,52 week

    Glucose metabolism indicator

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Sit and reach test(cm)

    Time frame: Baseline,12 week,52 week

    Motor system function: sit and reach test

Other outcomes

  1. hs-CRP(mg/L)

    Time frame: Baseline,12 week,52 week

    Inflammatory indicator:high-sensitivity C-reactive protein

  2. IL-1β(pg/mL)

    Time frame: Baseline,12 week,52 week

    Inflammatory indicator:interleukin-1β

  3. TNF-α(pg/mL)

    Time frame: Baseline,12 week,52 week

    Inflammatory indicator:tumor necrosis factor-α

  4. FMD(%)

    Time frame: Baseline,12 week,52 week

    Endothelial function indicator:flow mediated dilatation

  5. NO(μmol/mL)

    Time frame: Baseline,12 week,52 week

    Endothelial function indicator:nitric oxides

  6. PG(pg/mL)

    Time frame: Baseline,12 week,52 week

    Endothelial function indicator:prostaglandin

  7. cfPWV(m/s)

    Time frame: Baseline,12 week,52 week

    Atherosclerosis:carotid-femoral pulse wave velocity

  8. Whole genome gene expression profiling in peripheral blood mononuclear cells

    Time frame: Baseline,12 week,52 week

    Immunological indicator

  9. Thymic volume(cm^3)

    Time frame: Baseline,52 week

    Immunological indicator

  10. BMI(kg/m^2)

    Time frame: Baseline,12 week,52 week

    Anthropometric indicator:Body mass index

  11. Waist circumference(cm)

    Time frame: Baseline,12 week,52 week

    Anthropometric indicator

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Acronym: BLESS

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 31, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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