Baduanjin Lower Elevated Blood PreSsure Study

NCT05397535 | Completed

• 1 other identifier: 2022-1724
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elevated Blood Pressure

Keywords

Baduanjin; elevated blood pressure; antihypertensive effect; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 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)

  Baseline,12 week,52 week

• SBP(mmHg)

  Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week

• DBP(mmHg）

  Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week

• FBG(mmol/L)

  Baseline,12 week,52 week

• HbA1c(%)

  Baseline,12 week,52 week

Other Outcomes (11)

• hs-CRP(mg/L)

  Baseline,12 week,52 week

• IL-1β(pg/mL)

  Baseline,12 week,52 week

• TNF-α(pg/mL)

  Baseline,12 week,52 week

Study Arms (3)

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).

Behavioral: Brisk walking

Baduanjin group

EXPERIMENTAL

Participants in Baduanjin Group will practice Baduanjin singly for 52 weeks (≥5 days/week, about 30 minutes/day).

Behavioral: Baduanjin

Interventions

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.

Baduanjin group

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.

Brisk walking group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jing Li, MD,PhD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 31, 2022
• Study Start: June 5, 2022
• Primary Completion: July 4, 2024
• Study Completion: July 11, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)