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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study 2: deep breathing | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Study 1: expression of adrenomedullin (ADM) | Expression of gene adrenomedullin (ADM) in fold unit | Day 1 |
| Study 1: expression of angiopoietin-like 4 (ANGPTL4) | Expression of gene angiopoietin-like 4 (ANGPTL4) in fold unit | Day 1 |
| Study 1: expression of proto-oncogene c-Fos (FOS) | Expression of gene proto-oncogene c-Fos (FOS) in fold unit | Day 1 |
| Study 1: expression of prostaglandin-endoperoxide synthase 2 (PTGS2) | Expression of gene prostaglandin-endoperoxide synthase 2 (PTGS2) in fold unit | Day 1 |
| Study 1: expression of ubiquitin specific peptidase 8 (USP8) | Expression of gene ubiquitin specific peptidase 8 (USP8) in fold unit | Day 1 |
| Study 1: tumor necrosis factor-alpha | Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit | Day 1 |
| Study 1: interferon-gamma | Marker of inflammation interferon-gamma in picogram/milliliter unit | Day 1 |
| Study 2: systolic blood pressure | Systolic blood pressure in millimeter of mercury unit |
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Study 1:
Group of individuals with hypertension
Inclusion Criteria:
Exclusion Criteria:
Group of individuals with normal blood pressure
Inclusion Criteria:
Exclusion Criteria:
Study 2:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piyapong Prasertsri, Ph.D. | Contact | 6638103166 | piyapong@buu.ac.th | |
| Tadsawiya Padkao, Ph.D. | Contact | 6638103166 | tadsawiya@go.buu.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Allied Health Sciences, Burapha University | Recruiting | MueangChonburi | Changwat Chon Buri | 20131 | Thailand |
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Study 1 is a cross-sectional study model and study 2 is an experimental study model.
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Other than investigators, data collectors, and outcome adjudicators, different researchers were assigned as outcomes assessors and data analysts.
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| Study 2: 4-7-8 breathing | Other | 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 daily for a duration of 3 months. |
|
| Study 2: slow breathing with device | Other | 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. |
|
| Day 1 and Day 85 |
| Study 2: diastolic blood pressure | Diastolic blood pressure in millimeter of mercury unit | Day 1 and Day 85 |
| Study 2: systolic blood pressure coefficient of variation | Systolic blood pressure coefficient of variation in percentage unit | Day 1 and Day 85 |
| Study 2: diastolic blood pressure coefficient of variation | Diastolic blood pressure coefficient of variation in percentage unit | Day 1 and Day 85 |
| Study 2: tumor necrosis factor-alpha | Marker of inflammation tumor necrosis factor-alpha in picogram/milliliter unit | Day 1 and Day 85 |
| Study 2: interferon-gamma | Marker of inflammation interferon-gamma in picogram/milliliter unit | Day 1 and Day 85 |
| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| D009058 | Mouth Breathing |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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