Baduanjin Lower Elevated Blood PreSsure Study
- Conditions
- Elevated Blood Pressure
- Interventions
- Behavioral: BaduanjinBehavioral: Brisk walking
- Registration Number
- NCT05397535
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baduanjin group Baduanjin Participants in Baduanjin Group will practice Baduanjin singly for 52 weeks (≥5 days/week, about 30 minutes/day). Brisk walking group Brisk walking Participants in Brisk Walking Group will participate in brisk walking for 52 weeks (≥5 days/week, about 30 minutes/day).
- Primary Outcome Measures
Name Time Method Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 12 week 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 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 Outcome Measures
Name Time Method C-peptide Baseline,12 week,52 week Glucose metabolism indicator
FBG(mmol/L) Baseline,12 week,52 week Glucose metabolism indicator: fasting blood glucose
HbA1c(%) Baseline,12 week,52 week Glucose metabolism indicator: hemoglobin A1c
Total scores of The Short-Form-36 Health Survey (SF-36) Baseline,12 week,52 week The total scores range from 0-100, and the higher scores mean better outcomes
SBP(mmHg) Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week Blood pressure indicator:office systolic blood pressure
Total scores of Pittsburgh Sleep Quality Index(PSQI) Baseline,12 week,52 week The total scores range from 0-21, and the higher scores mean worse outcomes
Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L) Baseline,12 week,52 week Lipid metabolism indicators: total cholesterol , triglyceride , high density lipoprotein cholesterol, low density lipoprotein cholesterol
Total scores of Generalized Anxiety Disorder-7(GAD-7) Baseline,12 week,52 week The total scores range from 0-21, and the higher scores mean worse outcomes
Insulin Baseline,12 week,52 week Glucose metabolism indicator
Total scores of Neck Disability Index(NDI) Baseline,12 week,52 week The total scores range from 0-100%, and the higher scores mean worse 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) 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
DBP(mmHg） Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week Blood pressure indicator:office diastolic blood pressure
Total scores of Patient Health Questionnaire-9 items(PHQ-9) Baseline,12 week,52 week The total scores range from 0-27 , and the higher scores mean worse outcomes
Sit and reach test(cm) Baseline,12 week,52 week Motor system function: sit and reach test
Trial Locations
- Locations (1)
Fuwai Hospital
🇨🇳Beijing, Beijing, China