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| Name | Class |
|---|---|
| FundaĆ§Ć£o de Amparo Ć Pesquisa do Estado de SĆ£o Paulo | OTHER_GOV |
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This is a randomized, double-blind and sham-controlled clinical trial that aims to evaluate and compare the acute effect of full-body photobiomodulation (PBM) and modified ILIB (Intravascular laser irradiation of blood) on blood pressure, endothelial function and arterial stiffness in individuals with hypertension. Participants (n=48) will be equally, randomly and secretly allocated into one of 4 groups: Panel Group; Panel Sham Group; Modified ILIB group; and Modified ILIB Sham Group. Participants aged 40 to 60 years old, diagnosed with hypertension and using control drugs for at least 3 months will be included. Participants will be assessed at pre- and post-intervention for: BP; endothelial function; arterial stiffness; blood nitrite; and thermography. In the post-intervention period, the ambulatory blood pressure monitoring will also be carried out. Participants will receive a single application of PBM, which, depending on the group, may be full-body irradiation from an LED panel (660 nm; 25.34 J/cmĀ²; 42.24 mW/cmĀ²), modified ILIB (660 nm; 42,462 J/cmĀ²; 35.385 W/cmĀ²), or the respective sham therapies. Data homogeneity and normality will be verified by the Levene and Shapiro-Wilk tests, which will determine the choice of subsequent tests. A statistical significance of 5% will be considered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel Group | Experimental | Participants who will receive full-body photobiomodulation irradiation, from a panel of LEDs |
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| Panel Sham Group | Sham Comparator | Participants who will receive full-body photobiomodulation irradiation, with the device turned-off |
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| Modified ILIB Group | Experimental | Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method |
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| Modified ILIB Sham Group | Sham Comparator | Participants who will received photobiomodulation irradiation with the transcutaneous ILIB method, with the device turned-off |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panel Effective Photobiomodulation Therapy | Device | Photobiomodulation therapy is the use of low-power light in biological tissues through a non-ionizing source of light (600 to 1.100 nm), with variable power between 1 and 500 mW and therapeutic goals. This group will receive photobiomodulation from a whole-body panel of low intensity LEDs |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure | Diastolic blood pressure measured in millimeters of mercury (mmHg) | Acute effect (immediately post-intervention until 24 hours after) |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | systolic blood pressure measured in millimeters of mercury (mmHg) | Acute effect (immediately post-intervention until 24 hours after) |
| Mean Arterial Pressure | mean arterial pressure measured in millimeters of mercury (mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of SĆ£o Carlos | Recruiting | SĆ£o Carlos | SĆ£o Paulo | 13565-905 | Brazil |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Sham Panel Photobiomodulation Therapy | Device | Use of common red lamp to perform the sham photobiomodulation for the panel group |
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| Modified ILIB Sham Photobiomodulation Therapy | Device | ILIB Therapy device turned off for the sham ILIB therapy |
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| Modified ILIB Photobiomodulation Therapy | Device | Common laser used in ILIB mode for modified ILIB therapy |
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| Acute effect (immediately post-intervention until 24 hours after) |
| Endothelial Function | Endothelial function measured by flow-mediated dilation, with a brachial artery ultrasound | Acute effect (About 25 minutes post-intervention) |
| Arterial Stiffness | Arterial stiffness measured by pulse wave velocity | Acute effect (About 15 minutes post-intervention) |
| Blood Nitrite | Blood nitrite levels | Acute effect (1 hour post-intervention) |