Acute Effect of Photobiomodulation in Individuals with Hypertension

NCT06678698 · tracked via the Priya Life Science Brazil tracker

Sponsor

Universidade Federal de Sao Carlos

Phase

Not applicable

Started

2024-05-01

Last updated

2024-11-08

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

Panel Effective Photobiomodulation TherapySham Panel Photobiomodulation TherapyModified ILIB Sham Photobiomodulation TherapyModified ILIB Photobiomodulation Therapy

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

Study 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

Sex

ALL

Min age

40 Years

Max age

60 Years

Healthy volunteers

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

Primary outcome measure(s)

Diastolic Blood Pressure — Acute effect (immediately post-intervention until 24 hours after)
Diastolic blood pressure measured in millimeters of mercury (mmHg)

Trial sites (1)

Facility	City	Region	Status
Federal University of São Carlos	São Carlos	São Paulo	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06678698 on ClinicalTrials.gov ↗ ← All trials in Brazil