Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: f
View:

• Sedentary or irregularly inactive individuals (IPAQ)

• Both sexes

• Age between 40 to 60 years old

• Clinical diagnosis of hypertension for at least 3 months with difficulty in blood pressure control

• Hypertension classification up to stage 2

• Individuals who have a prescription for hypertension control drugs and have been using these drugs for at least 3 months

Locations
Other Locations
Brazil
Federal University of São Carlos
RECRUITING
São Carlos
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-01-30
Participants
Target number of participants: 48
Treatments
Experimental: Panel Group
Participants who will receive full-body photobiomodulation irradiation, from a panel of LEDs
Sham_comparator: Panel Sham Group
Participants who will receive full-body photobiomodulation irradiation, with the device turned-off
Experimental: Modified ILIB Group
Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method
Sham_comparator: Modified ILIB Sham Group
Participants who will received photobiomodulation irradiation with the transcutaneous ILIB method, with the device turned-off
Related Therapeutic Areas
Sponsors
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Leads: Universidade Federal de Sao Carlos

This content was sourced from clinicaltrials.gov

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