Elevated Blood Pressure
Conditions
Keywords
Baduanjin, elevated blood pressure, antihypertensive effect, randomized controlled trial
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.
Interventions
BEHAVIORALBaduanjin
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.
BEHAVIORALBrisk 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.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| SBP(mmHg) | Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week | Blood pressure indicator:office systolic blood pressure |
| DBP(mmHg） | Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week | Blood pressure indicator:office diastolic blood pressure |
| 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 |
| Insulin | Baseline,12 week,52 week | Glucose metabolism indicator |
| C-peptide | Baseline,12 week,52 week | Glucose metabolism indicator |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Sit and reach test(cm) | Baseline,12 week,52 week | Motor system function: sit and reach test |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| FMD(%) | Baseline,12 week,52 week | Endothelial function indicator:flow mediated dilatation |
| NO(μmol/mL) | Baseline,12 week,52 week | Endothelial function indicator:nitric oxides |
| PG(pg/mL) | Baseline,12 week,52 week | Endothelial function indicator:prostaglandin |
| cfPWV(m/s) | Baseline,12 week,52 week | Atherosclerosis:carotid-femoral pulse wave velocity |
| Whole genome gene expression profiling in peripheral blood mononuclear cells | Baseline,12 week,52 week | Immunological indicator |
| Thymic volume(cm^3) | Baseline,52 week | Immunological indicator |
| BMI(kg/m^2) | Baseline,12 week,52 week | Anthropometric indicator:Body mass index |
| Waist circumference(cm) | Baseline,12 week,52 week | Anthropometric indicator |
| IL-1β(pg/mL) | Baseline,12 week,52 week | Inflammatory indicator:interleukin-1β |
| TNF-α(pg/mL) | Baseline,12 week,52 week | Inflammatory indicator:tumor necrosis factor-α |
| hs-CRP(mg/L) | Baseline,12 week,52 week | Inflammatory indicator:high-sensitivity C-reactive protein |
Countries
China
Outcome results
None listed