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Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial
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/cm²; 42.24 mW/cm²), modified ILIB (660 nm; 42,462 J/cm²; 35.385 W/cm²), 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.
Age
40 - 60 years
Sex
ALL
Healthy Volunteers
No
Federal University of São Carlos
São Carlos, São Paulo, Brazil
Start Date
May 1, 2024
Primary Completion Date
January 30, 2025
Completion Date
January 30, 2025
Last Updated
November 8, 2024
48
ESTIMATED participants
Panel Effective Photobiomodulation Therapy
DEVICE
Sham Panel Photobiomodulation Therapy
DEVICE
Modified ILIB Sham Photobiomodulation Therapy
DEVICE
Modified ILIB Photobiomodulation Therapy
DEVICE
Lead Sponsor
Universidade Federal de Sao Carlos
Collaborators
Data Source & Attribution
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