Expression of Genes Relating Hypertension and Efficacy of 4-7-8 Breathing Control on Reducing Blood Pressure

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Study 2: deep breathing
  Participants in the deep breathing group will be randomized to receive a diaphragmatic deep breathing program. They will be instructed to practice deep breathing at a rate of 6-10 breaths per minute for 15 minutes, twice daily, every day for a duration of 3 months.
• Другое Study 2: 4-7-8 breathing
  Participants in the 4-7-8 breathing group will be randomized to receive a 4-7-8 breathing program. They will follow the 4-7-8 breathing training program, which involves inhaling for 4 seconds, holding the breath for 7 seconds, and exhaling for 8 seconds, counted as one cycle. This pattern is to be repeated for 6 cycles to complete one set. They will perform 12 sets per day-6 sets in the morning and 6 sets in the evening-with normal breathing between each set. This routine will be carried out dai
• Другое Study 2: slow breathing with device
  Participants in the slow breathing with device group will be randomized to receive a slow breathing with device. They will undergo deep breathing training using a resistance-based breathing device called BreathMax, set at 25% of their maximal inspiratory pressure. The breathing rate will be 6 breaths per minute, continuously for 15 minutes, twice a day. This routine will be performed daily for a duration of 3 months.

Первичные конечные точки

• Study 1: expression of adrenomedullin (ADM) [Срок оценки: Day 1]
• Study 1: expression of angiopoietin-like 4 (ANGPTL4) [Срок оценки: Day 1]
• Study 1: expression of proto-oncogene c-Fos (FOS) [Срок оценки: Day 1]
• Study 1: expression of prostaglandin-endoperoxide synthase 2 (PTGS2) [Срок оценки: Day 1]
• Study 1: expression of ubiquitin specific peptidase 8 (USP8) [Срок оценки: Day 1]
• Study 1: tumor necrosis factor-alpha [Срок оценки: Day 1]
• Study 1: interferon-gamma [Срок оценки: Day 1]
• Study 2: systolic blood pressure [Срок оценки: Day 1 and Day 85]
• Study 2: diastolic blood pressure [Срок оценки: Day 1 and Day 85]
• Study 2: systolic blood pressure coefficient of variation [Срок оценки: Day 1 and Day 85]

Критерии участия

Study 1:

• Group of individuals with hypertension

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

• 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

Критерии исключения

• 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

Study 2:

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Таиланд · 1 центр

• Faculty of Allied Health Sciences, Burapha University — MueangChonburi

Идентификаторы

NCT: NCT07018128 · IRB1-046/2568

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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