Acute Effect of Photobiomodulation in Individuals with Hypertension

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorUniversidade Federal de Sao Carlos

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

48 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Universidade Federal de Sao Carlos

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator