Acute Effect of Photobiomodulation in Individuals with Hypertension

Universidade Federal de Sao Carlos

Status: Enrolling

Conditions: Hypertension

Treatments: Device: Sham Panel Photobiomodulation Therapy; Device: Modified ILIB Photobiomodulation Therapy; Device: Panel Effective Photobiomodulation Therapy; Device: Modified ILIB Sham Photobiomodulation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06678698

UFSaoCarlosPBM

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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48 participants in 4 patient groups

Panel Group

Experimental group

Description:

Participants who will receive full-body photobiomodulation irradiation, from a panel of LEDs

Treatment:

Device: Panel Effective Photobiomodulation Therapy

Panel Sham Group

Sham Comparator group

Description:

Participants who will receive full-body photobiomodulation irradiation, with the device turned-off

Treatment:

Device: Sham Panel Photobiomodulation Therapy

Modified ILIB Group

Experimental group

Description:

Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method

Treatment:

Device: Modified ILIB Photobiomodulation Therapy

Modified ILIB Sham Group

Sham Comparator group

Description:

Participants who will received photobiomodulation irradiation with the transcutaneous ILIB method, with the device turned-off

Treatment:

Device: Modified ILIB Sham Photobiomodulation Therapy