Acute Effect of Photobiomodulation in Individuals with Hypertension

Universidade Federal de Sao Carlos48 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypertension

Panel Effective Photobiomodulation TherapyDEVICE

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 TherapyDEVICE

Use of common red lamp to perform the sham photobiomodulation for the panel group

Modified ILIB Sham Photobiomodulation TherapyDEVICE

ILIB Therapy device turned off for the sham ILIB therapy

Modified ILIB Photobiomodulation TherapyDEVICE

Common laser used in ILIB mode for modified ILIB therapy

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Diastolic Blood Pressure

Diastolic blood pressure measured in millimeters of mercury (mmHg)

Time frame: Acute effect (immediately post-intervention until 24 hours after)

Secondary Outcomes

Systolic Blood Pressure

systolic blood pressure measured in millimeters of mercury (mmHg)

Time frame: Acute effect (immediately post-intervention until 24 hours after)

Mean Arterial Pressure

mean arterial pressure measured in millimeters of mercury (mmHg)

Time frame: Acute effect (immediately post-intervention until 24 hours after)

Endothelial Function

Endothelial function measured by flow-mediated dilation, with a brachial artery ultrasound

Time frame: Acute effect (About 25 minutes post-intervention)

Arterial Stiffness

Arterial stiffness measured by pulse wave velocity

Time frame: Acute effect (About 15 minutes post-intervention)

Blood Nitrite

Blood nitrite levels

Time frame: Acute effect (1 hour post-intervention)

Acute Effect of Photobiomodulation in Individuals with Hypertension

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes