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Acute Effect of Photobiomodulation in Individuals with Hypertension

Acute Effect of Photobiomodulation in Individuals with Hypertension

Recruiting
40-60 years
All
Phase N/A

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Overview

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diabetes diagnosis
  • Smokers
  • BMI > 30 kg/m²
  • Cardiac pacemaker use
  • Presence of arrhythmias or other decompensated cardiovascular diseases
  • Musculoskeletal, orthopedic or neurological conditions that make it unable to participate in the procedures
  • Presence of cognitive deficits that make it difficult to understand the assessments
  • Presence of active neoplasia, under suspicion or after 5 years in remission period
  • Presence of tattoos (covering a large body area, or the anterior wrist region)
  • Photosensitive drugs use
  • Pregnant women or under suspicion
  • Presence of epilepsy or seizures
  • Participants who present a systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg on the day of the intervention

Study details
    Hypertension

NCT06678698

Universidade Federal de Sao Carlos

14 October 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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