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临床试验/NCT07018128
NCT07018128招募中不适用

Expression of Genes Relating Hypertension in Thailand and the Efficacy of 4-7-8 Breathing Control on Reducing Blood Pressure in Individuals With Hypertension

Burapha University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Study 1: expression of adrenomedullin (ADM)

研究概览

简要总结

This study consists of two sub-studies. Study 1 investigates gene expression related to the development of hypertension in Thailand, and Study 2 examines the effectiveness of the 4-7-8 breathing technique in reducing blood pressure in individuals with hypertension.

详细描述

In Study 1, the sample group includes 200 individuals aged 18-59 years, originating from various regions of Thailand but currently residing in the eastern region. Participants may have normal blood pressure, high blood pressure, or have been diagnosed with hypertension. Blood samples from the participants will be analyzed for the following variables: 1) expression of five genes-adrenomedullin (ADM), angiopoietin-like 4 (ANGPTL4), proto-oncogene c-Fos (FOS), prostaglandin-endoperoxide synthase 2 (PTGS2), and ubiquitin specific peptidase 8 (USP8), and 2) markers of inflammation-tumor necrosis factor-alpha and interferon-gamma levels in the blood.

In Study 2, the sample group includes 75 volunteers from Study 1 who are interested in participating. These volunteers will be randomly assigned into three groups of 25 people each. The first group is a control group whose participants will not receive any breathing training. The second group will practice the 4-7-8 breathing technique, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds-this constitutes one cycle. They will repeat this for 6 cycles per set, three sets per day, with normal breathing between sets. The third group will practice deep diaphragmatic breathing at a rate of 6-10 breaths per minute for 15 minutes, twice a day. Participants in both the second and third groups are required to follow their assigned breathing programs daily for three consecutive months. At the end of the three months, all participants will be assessed on the same variables measured before the intervention: 1) systolic and diastolic blood pressure levels, 2) blood pressure variability, and 3) inflammation markers, specifically tumor necrosis factor-alpha and interferon-gamma levels in the blood.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Other than investigators, data collectors, and outcome adjudicators, different researchers were assigned as outcomes assessors and data analysts.

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Group of individuals with hypertension
  • Inclusion Criteria:
  • Male or female
  • Aged between 18-59 years
  • Of Thai ethnicity
  • Diagnosed with hypertension, defined as having an SBP of 140 mmHg or higher, or a DBP of 90 mmHg or higher, or having previously been diagnosed with hypertension and currently taking antihypertensive medication
  • Originally from various regions of Thailand and currently residing in the eastern region

排除标准

  • Has heart disease, such as valvular stenosis or regurgitation, coronary artery disease, or heart failure
  • Has obesity, defined as having a body mass index (BMI) of 30 kg/m² or higher
  • Has a fever or is currently experiencing an infectious disease, such as COVID-19, the flu, or other infections
  • Group of individuals with normal blood pressure
  • Inclusion Criteria:
  • Male or female
  • Aged between 18-59 years
  • Of Thai ethnicity
  • Does not have hypertension, defined as having an SBP below 130 mmHg and a DBP below 85 mmHg, with no prior diagnosis of hypertension and no history of taking antihypertensive medication
  • Originally from various regions of Thailand and currently residing in the eastern region
  • Exclusion Criteria:
  • Has heart disease, such as valvular stenosis or regurgitation, coronary artery disease, or heart failure
  • Has obesity, defined as having a body mass index (BMI) of 30 kg/m² or higher
  • Has a fever or is currently experiencing an infectious disease, such as COVID-19, the flu, or other infections
  • Inclusion Criteria:
  • Male or female, aged 35-59 years
  • Diagnosed with hypertension, with blood pressure levels above the normal range, defined as SBP of 130 mmHg or higher, or DBP of 85 mmHg or higher, and currently taking medication
  • Originally from various regions of Thailand and currently residing in the eastern region
  • Able to communicate effectively
  • Exclusion Criteria:
  • Has respiratory diseases, cardiovascular diseases, cerebrovascular disease, kidney disease, cancer, or immune-related conditions such as allergies, autoimmune diseases (e.g., SLE), immunodeficiency, or rheumatoid arthritis
  • Is obese, defined as having a body mass index (BMI) of 30 kg/m² or higher
  • Has a fever or is currently infected, such as with COVID-19, the flu, or other infectious diseases
  • Is currently pregnant, breastfeeding, or has a history of pregnancy within the 6 months prior to participating in the study

研究组 & 干预措施

Study 2: control group

No Intervention

Participants will not receive any breathing training.

Study 2: deep breathing

Active Comparator

Participants will practice deep diaphragmatic breathing at a rate of 6-10 breaths per minute for 15 minutes, twice a day. Participants are required to follow their assigned breathing programs daily for three consecutive months.

干预措施: Study 2: deep breathing (Other)

Study 2: 4-7-8 breathing

Experimental

Participants will practice the 4-7-8 breathing technique, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds-this constitutes one cycle. They will repeat this for 6 cycles per set, three sets per day, with normal breathing between sets. Participants are required to follow their assigned breathing programs daily for three consecutive months.

干预措施: Study 2: 4-7-8 breathing (Other)

Study 2: slow breathing with device

Active Comparator

Participants will practice deep breathing using a resistance-based breathing device called "BreathMax" which provides water pressure resistance set at 25% of their maximum inspiratory capacity. The breathing rate will be set at 6 breaths per minute, continued for 15 minutes per session, twice daily. Participants are required to follow their assigned breathing programs daily for three consecutive months.

干预措施: Study 2: slow breathing with device (Other)

结局指标

主要结局

Study 1: expression of adrenomedullin (ADM)

时间窗: Day 1

Expression of gene adrenomedullin (ADM) in fold unit

Study 1: expression of angiopoietin-like 4 (ANGPTL4)

时间窗: Day 1

Expression of gene angiopoietin-like 4 (ANGPTL4) in fold unit

Study 1: expression of proto-oncogene c-Fos (FOS)

时间窗: Day 1

Expression of gene proto-oncogene c-Fos (FOS) in fold unit

Study 1: expression of prostaglandin-endoperoxide synthase 2 (PTGS2)

时间窗: Day 1

Expression of gene prostaglandin-endoperoxide synthase 2 (PTGS2) in fold unit

Study 1: expression of ubiquitin specific peptidase 8 (USP8)

时间窗: Day 1

Expression of gene ubiquitin specific peptidase 8 (USP8) in fold unit

Study 1: tumor necrosis factor-alpha

时间窗: Day 1

Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit

Study 1: interferon-gamma

时间窗: Day 1

Marker of inflammation interferon-gamma in picogram/milliliter unit

Study 2: systolic blood pressure

时间窗: Day 1 and Day 85

Systolic blood pressure in millimeter of mercury unit

Study 2: diastolic blood pressure

时间窗: Day 1 and Day 85

Diastolic blood pressure in millimeter of mercury unit

Study 2: systolic blood pressure coefficient of variation

时间窗: Day 1 and Day 85

Systolic blood pressure coefficient of variation in percentage unit

Study 2: diastolic blood pressure coefficient of variation

时间窗: Day 1 and Day 85

Diastolic blood pressure coefficient of variation in percentage unit

Study 2: tumor necrosis factor-alpha

时间窗: Day 1 and Day 85

Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit

Study 2: interferon-gamma

时间窗: Day 1 and Day 85

Marker of inflammation interferon-gamma in picogram/milliliter unit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piyapong Prasertsri

Associate Professor Dr.

Burapha University

研究点 (2)

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