Baduanjin Lower Elevated Blood PreSsure Study

Study Overview
=================
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.

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

Conditions
-----------------
Elevated Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: Baduanjin
* Behavioral: Brisk walking


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Self-directed exercise group<br>Participants in the self-directed exercise group will choose the type and duration of exercise by their preference. | |
| Active Comparator: Brisk walking group<br>Participants in Brisk Walking Group will participate in brisk walking for 52 weeks (≥5 days/week, about 30 minutes/day). | Behavioral: Brisk walking<br>* 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.<br>|
| Experimental: Baduanjin group<br>Participants in Baduanjin Group will practice Baduanjin singly for 52 weeks (≥5 days/week, about 30 minutes/day). | Behavioral: Baduanjin<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Baduanjin, elevated blood pressure, antihypertensive effect, randomized controlled trial