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Baduanjin Lower Elevated Blood PreSsure Study (BLESS)

Primary Purpose

Elevated Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baduanjin
Brisk walking
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elevated Blood Pressure focused on measuring Baduanjin, elevated blood pressure, antihypertensive effect, randomized controlled trial

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Self-directed exercise group

Brisk walking group

Baduanjin group

Arm Description

Participants in the self-directed exercise group will choose the type and duration of exercise by their preference.

Participants in Brisk Walking Group will participate in brisk walking for 52 weeks (≥5 days/week, about 30 minutes/day).

Participants in Baduanjin Group will practice Baduanjin singly for 52 weeks (≥5 days/week, about 30 minutes/day).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
SBP(mmHg)
Blood pressure indicator:office systolic blood pressure
DBP(mmHg）
Blood pressure indicator:office diastolic blood pressure
FBG(mmol/L)
Glucose metabolism indicator: fasting blood glucose
HbA1c(%)
Glucose metabolism indicator: hemoglobin A1c
Insulin
Glucose metabolism indicator
C-peptide
Glucose metabolism indicator
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
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
Total scores of Pittsburgh Sleep Quality Index(PSQI)
The total scores range from 0-21, and the higher scores mean worse outcomes
Total scores of Generalized Anxiety Disorder-7(GAD-7)
The total scores range from 0-21, and the higher scores mean worse outcomes
Total scores of Patient Health Questionnaire-9 items(PHQ-9)
The total scores range from 0-27 , and the higher scores mean worse outcomes
Total scores of Neck Disability Index(NDI)
The total scores range from 0-100%, and the higher scores mean worse outcomes
Sit and reach test(cm)
Motor system function: sit and reach test

Full Information

First Posted
May 20, 2022
Last Updated
September 11, 2023
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05397535
Brief Title
Baduanjin Lower Elevated Blood PreSsure Study
Acronym
BLESS
Official Title
Traditional Exercise as Convenient Approach to Improve Health 1-Baduanjin Lower Elevated Blood PreSsure Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Blood Pressure
Keywords
Baduanjin, elevated blood pressure, antihypertensive effect, randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-directed exercise group
Arm Type
No Intervention
Arm Description
Participants in the self-directed exercise group will choose the type and duration of exercise by their preference.
Arm Title
Brisk walking group
Arm Type
Active Comparator
Arm Description
Participants in Brisk Walking Group will participate in brisk walking for 52 weeks (≥5 days/week, about 30 minutes/day).
Arm Title
Baduanjin group
Arm Type
Experimental
Arm Description
Participants in Baduanjin Group will practice Baduanjin singly for 52 weeks (≥5 days/week, about 30 minutes/day).
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brisk walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 12 week
Description
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.
Time Frame
Baseline, 12 week
Title
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 52 week
Description
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.
Time Frame
Baseline, 52 week
Secondary Outcome Measure Information:
Title
Other blood pressure indicators: daytime mean SBP(mmHg), nighttime mean SBP(mmHg), 24-h DBP(mmHg), daytime mean DBP(mmHg), nighttime mean DBP(mmHg)
Description
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
Time Frame
Baseline,12 week,52 week
Title
SBP(mmHg)
Description
Blood pressure indicator:office systolic blood pressure
Time Frame
Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
Title
DBP(mmHg）
Description
Blood pressure indicator:office diastolic blood pressure
Time Frame
Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week
Title
FBG(mmol/L)
Description
Glucose metabolism indicator: fasting blood glucose
Time Frame
Baseline,12 week,52 week
Title
HbA1c(%)
Description
Glucose metabolism indicator: hemoglobin A1c
Time Frame
Baseline,12 week,52 week
Title
Insulin
Description
Glucose metabolism indicator
Time Frame
Baseline,12 week,52 week
Title
C-peptide
Description
Glucose metabolism indicator
Time Frame
Baseline,12 week,52 week
Title
Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L)
Description
Lipid metabolism indicators: total cholesterol , triglyceride , high density lipoprotein cholesterol, low density lipoprotein cholesterol
Time Frame
Baseline,12 week,52 week
Title
Total scores of The Short-Form-36 Health Survey (SF-36)
Description
The total scores range from 0-100, and the higher scores mean better outcomes
Time Frame
Baseline,12 week,52 week
Title
Total scores of Pittsburgh Sleep Quality Index(PSQI)
Description
The total scores range from 0-21, and the higher scores mean worse outcomes
Time Frame
Baseline,12 week,52 week
Title
Total scores of Generalized Anxiety Disorder-7(GAD-7)
Description
The total scores range from 0-21, and the higher scores mean worse outcomes
Time Frame
Baseline,12 week,52 week
Title
Total scores of Patient Health Questionnaire-9 items(PHQ-9)
Description
The total scores range from 0-27 , and the higher scores mean worse outcomes
Time Frame
Baseline,12 week,52 week
Title
Total scores of Neck Disability Index(NDI)
Description
The total scores range from 0-100%, and the higher scores mean worse outcomes
Time Frame
Baseline,12 week,52 week
Title
Sit and reach test(cm)
Description
Motor system function: sit and reach test
Time Frame
Baseline,12 week,52 week
Other Pre-specified Outcome Measures:
Title
hs-CRP(mg/L)
Description
Inflammatory indicator:high-sensitivity C-reactive protein
Time Frame
Baseline,12 week,52 week
Title
IL-1β(pg/mL)
Description
Inflammatory indicator:interleukin-1β
Time Frame
Baseline,12 week,52 week
Title
TNF-α(pg/mL)
Description
Inflammatory indicator:tumor necrosis factor-α
Time Frame
Baseline,12 week,52 week
Title
FMD(%)
Description
Endothelial function indicator:flow mediated dilatation
Time Frame
Baseline,12 week,52 week
Title
NO(μmol/mL)
Description
Endothelial function indicator:nitric oxides
Time Frame
Baseline,12 week,52 week
Title
PG(pg/mL)
Description
Endothelial function indicator:prostaglandin
Time Frame
Baseline,12 week,52 week
Title
cfPWV(m/s)
Description
Atherosclerosis:carotid-femoral pulse wave velocity
Time Frame
Baseline,12 week,52 week
Title
Whole genome gene expression profiling in peripheral blood mononuclear cells
Description
Immunological indicator
Time Frame
Baseline,12 week,52 week
Title
Thymic volume(cm^3)
Description
Immunological indicator
Time Frame
Baseline,52 week
Title
BMI(kg/m^2)
Description
Anthropometric indicator:Body mass index
Time Frame
Baseline,12 week,52 week
Title
Waist circumference(cm)
Description
Anthropometric indicator
Time Frame
Baseline,12 week,52 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Li, MD,PhD
Phone
+86(10)6086 6077
Email
jing.li@fwoxford.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lihua Zhang, MD,PhD
Phone
15210909705
Email
lihua.zhang@fwoxford.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Li, MD,PhD
Organizational Affiliation
National Center for Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boxuan Pu
Phone
+8613933072467
Email
boxuan.pu@fwoxford.org

12. IPD Sharing Statement

Plan to Share IPD
No

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