Baduanjin Lower Elevated Blood PreSsure Study (BLESS)

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: Completed
• Conditions: Elevated Blood Pressure
• Intervention / Treatment: Behavioral: Brisk walking; Behavioral: Baduanjin

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 52 week

Secondary Outcome Measures

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)	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)	Blood pressure indicator:office systolic blood pressure	Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
DBP(mmHg）	Blood pressure indicator:office diastolic blood pressure	Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
FBG(mmol/L)	Glucose metabolism indicator: fasting blood glucose	Baseline,12 week,52 week
HbA1c(%)	Glucose metabolism indicator: hemoglobin A1c	Baseline,12 week,52 week
Insulin	Glucose metabolism indicator	Baseline,12 week,52 week
C-peptide	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)	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)	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)	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)	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)	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)	The total scores range from 0-100%, and the higher scores mean worse outcomes	Baseline,12 week,52 week
Sit and reach test(cm)	Motor system function: sit and reach test	Baseline,12 week,52 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
hs-CRP(mg/L)	Inflammatory indicator:high-sensitivity C-reactive protein	Baseline,12 week,52 week
IL-1β(pg/mL)	Inflammatory indicator:interleukin-1β	Baseline,12 week,52 week
TNF-α(pg/mL)	Inflammatory indicator:tumor necrosis factor-α	Baseline,12 week,52 week
FMD(%)	Endothelial function indicator:flow mediated dilatation	Baseline,12 week,52 week
NO(μmol/mL)	Endothelial function indicator:nitric oxides	Baseline,12 week,52 week
PG(pg/mL)	Endothelial function indicator:prostaglandin	Baseline,12 week,52 week
cfPWV(m/s)	Atherosclerosis:carotid-femoral pulse wave velocity	Baseline,12 week,52 week
Whole genome gene expression profiling in peripheral blood mononuclear cells	Immunological indicator	Baseline,12 week,52 week
Thymic volume(cm^3)	Immunological indicator	Baseline,52 week
BMI(kg/m^2)	Anthropometric indicator:Body mass index	Baseline,12 week,52 week
Waist circumference(cm)	Anthropometric indicator	Baseline,12 week,52 week

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Jing Li, MD,PhD, National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2022
• Primary Completion (Actual): July 4, 2024
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; Baduanjin; antihypertensive effect; elevated blood pressure
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID 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