Baduanjin Lower Elevated Blood PreSsure Study

Elevated Blood Pressure Clinical Trial

— BLESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397535
• Other study ID #: 2022-1724
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Jing Li, MD,PhD
• Phone: +86(10)6086 6077
• Email: jing.li[@]fwoxford.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hs-CRP(mg/L)	Inflammatory indicator:high-sensitivity C-reactive protein	Baseline,12 week,52 week
Other	IL-1ß(pg/mL)	Inflammatory indicator:interleukin-1ß	Baseline,12 week,52 week
Other	TNF-a(pg/mL)	Inflammatory indicator:tumor necrosis factor-a	Baseline,12 week,52 week
Other	FMD(%)	Endothelial function indicator:flow mediated dilatation	Baseline,12 week,52 week
Other	NO(µmol/mL)	Endothelial function indicator:nitric oxides	Baseline,12 week,52 week
Other	PG(pg/mL)	Endothelial function indicator:prostaglandin	Baseline,12 week,52 week
Other	cfPWV(m/s)	Atherosclerosis:carotid-femoral pulse wave velocity	Baseline,12 week,52 week
Other	Whole genome gene expression profiling in peripheral blood mononuclear cells	Immunological indicator	Baseline,12 week,52 week
Other	Thymic volume(cm^3)	Immunological indicator	Baseline,52 week
Other	BMI(kg/m^2)	Anthropometric indicator:Body mass index	Baseline,12 week,52 week
Other	Waist circumference(cm)	Anthropometric indicator	Baseline,12 week,52 week
Primary	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
Primary	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	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
Secondary	SBP(mmHg)	Blood pressure indicator:office systolic blood pressure	Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
Secondary	DBP(mmHg)	Blood pressure indicator:office diastolic blood pressure	Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
Secondary	FBG(mmol/L)	Glucose metabolism indicator: fasting blood glucose	Baseline,12 week,52 week
Secondary	HbA1c(%)	Glucose metabolism indicator: hemoglobin A1c	Baseline,12 week,52 week
Secondary	Insulin	Glucose metabolism indicator	Baseline,12 week,52 week
Secondary	C-peptide	Glucose metabolism indicator	Baseline,12 week,52 week
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sit and reach test(cm)	Motor system function: sit and reach test	Baseline,12 week,52 week