Acute Effect of Photobiomodulation in Individuals with Hypertension

Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Device: Panel Effective Photobiomodulation Therapy; Device: Sham Panel Photobiomodulation Therapy; Device: Modified ILIB Photobiomodulation Therapy; Device: Modified ILIB Sham Photobiomodulation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil, 13565-905
      • Recruiting
      • Federal University of São Carlos
      • Contact: Lara Espósito, PT; Phone Number: +551633518985; Email: larabataglia@estudante.ufscar.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel Group; Participants who will receive full-body photobiomodulation irradiation, from a panel of LEDs	Device: 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 Comparator: Panel Sham Group; Participants who will receive full-body photobiomodulation irradiation, with the device turned-off	Device: Sham Panel Photobiomodulation Therapy; Use of common red lamp to perform the sham photobiomodulation for the panel group
Experimental: Modified ILIB Group; Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method	Device: Modified ILIB Photobiomodulation Therapy; Common laser used in ILIB mode for modified ILIB therapy
Sham Comparator: Modified ILIB Sham Group; Participants who will received photobiomodulation irradiation with the transcutaneous ILIB method, with the device turned-off	Device: Modified ILIB Sham Photobiomodulation Therapy; ILIB Therapy device turned off for the sham ILIB therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure	Diastolic blood pressure measured in millimeters of mercury (mmHg)	Acute effect (immediately post-intervention until 24 hours after)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	systolic blood pressure measured in millimeters of mercury (mmHg)	Acute effect (immediately post-intervention until 24 hours after)
Mean Arterial Pressure	mean arterial pressure measured in millimeters of mercury (mmHg)	Acute effect (immediately post-intervention until 24 hours after)
Arterial Stiffness	Arterial stiffness measured by pulse wave velocity	Acute effect (About 15 minutes post-intervention)
Blood Nitrite	Blood nitrite levels	Acute effect (1 hour post-intervention)
Endothelial Function	Endothelial function measured by flow-mediated dilation, with a brachial artery ultrasound	Acute effect (About 25 minutes post-intervention)

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: The São Paulo Research Foundation (FAPESP)

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: hypertension; photobiomodulation; low-level light therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: UFSaoCarlosPBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No