About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Diabetes diagnosis
Smokers
BMI > 30 kg/m²
Cardiac pacemaker use
Trial design
Treatments tested in this trial
- Panel Effective Photobiomodulation Therapy
- Sham Panel Photobiomodulation Therapy
- Modified ILIB Sham Photobiomodulation Therapy
- Modified ILIB Photobiomodulation Therapy
Treatment groups
Sponsors and collaborators
Universidade Federal de Sao Carlos
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator