Clinical Research Directory
Browse clinical research sites, groups, and studies.
Acute Effect of Photobiomodulation in Individuals with Hypertension
Sponsor: Universidade Federal de Sao Carlos
Summary
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.
Official title: Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
40 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-05-01
Completion Date
2025-01-30
Last Updated
2024-11-08
Healthy Volunteers
No
Conditions
Interventions
Panel Effective Photobiomodulation Therapy
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
Sham Panel Photobiomodulation Therapy
Use of common red lamp to perform the sham photobiomodulation for the panel group
Modified ILIB Sham Photobiomodulation Therapy
ILIB Therapy device turned off for the sham ILIB therapy
Modified ILIB Photobiomodulation Therapy
Common laser used in ILIB mode for modified ILIB therapy
Locations (1)
Federal University of São Carlos
São Carlos, São Paulo, Brazil