Clinical trial NCT05397535: Baduanjin Lower Elevated Blood PreSsure Study
Official title: Traditional Exercise as Convenient Approach to Improve Health 1-Baduanjin Lower Elevated Blood PreSsure Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elevated Blood Pressure
Keywords: Baduanjin
elevated blood pressure
antihypertensive effect
randomized controlled trial
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-05-31
Enrollment: 216
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 12 week
timeFrame: Baseline, 12 week
measure: Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 52 week
timeFrame: Baseline, 52 week
Secondary outcomes:
measure: Other blood pressure indicators: daytime mean SBP(mmHg), nighttime mean SBP(mmHg), 24-h DBP(mmHg), daytime mean DBP(mmHg), nighttime mean DBP(mmHg)
timeFrame: Baseline,12 week,52 week
measure: SBP(mmHg)
timeFrame: Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
measure: DBP(mmHg）
timeFrame: Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
measure: FBG(mmol/L)
timeFrame: Baseline,12 week,52 week
measure: HbA1c(%)
timeFrame: Baseline,12 week,52 week
measure: Insulin
timeFrame: Baseline,12 week,52 week
measure: C-peptide
timeFrame: Baseline,12 week,52 week
measure: Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L)
timeFrame: Baseline,12 week,52 week
measure: Total scores of The Short-Form-36 Health Survey (SF-36)
timeFrame: Baseline,12 week,52 week
measure: Total scores of Pittsburgh Sleep Quality Index(PSQI)
timeFrame: Baseline,12 week,52 week
measure: Total scores of Generalized Anxiety Disorder-7(GAD-7)
timeFrame: Baseline,12 week,52 week
measure: Total scores of Patient Health Questionnaire-9 items(PHQ-9)
timeFrame: Baseline,12 week,52 week
measure: Total scores of Neck Disability Index(NDI)
timeFrame: Baseline,12 week,52 week
measure: Sit and reach test(cm)
timeFrame: Baseline,12 week,52 week
Other outcomes:
measure: hs-CRP(mg/L)
timeFrame: Baseline,12 week,52 week
measure: IL-1β(pg/mL)
timeFrame: Baseline,12 week,52 week
measure: TNF-α(pg/mL)
timeFrame: Baseline,12 week,52 week
measure: FMD(%)
timeFrame: Baseline,12 week,52 week
measure: NO(μmol/mL)
timeFrame: Baseline,12 week,52 week
measure: PG(pg/mL)
timeFrame: Baseline,12 week,52 week
measure: cfPWV(m/s)
timeFrame: Baseline,12 week,52 week
measure: Whole genome gene expression profiling in peripheral blood mononuclear cells
timeFrame: Baseline,12 week,52 week
measure: Thymic volume(cm^3)
timeFrame: Baseline,52 week
measure: BMI(kg/m^2)
timeFrame: Baseline,12 week,52 week
measure: Waist circumference(cm)
timeFrame: Baseline,12 week,52 week
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: National Center for Cardiovascular Diseases
name: Jing Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: