Acute Effect of Photobiomodulation in Individuals with Hypertension

NCT06678698 | Recruiting

• 1 other identifier: UFSaoCarlosPBM
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

hypertension; photobiomodulation; low-level light therapy

Outcome Measures

Primary Outcomes (1)

• Diastolic Blood Pressure

  Diastolic blood pressure measured in millimeters of mercury (mmHg)

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

Secondary Outcomes (5)

• Systolic Blood Pressure

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

• Mean Arterial Pressure

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

• Endothelial Function

  Acute effect (About 25 minutes post-intervention)

• Arterial Stiffness

  Acute effect (About 15 minutes post-intervention)

• Blood Nitrite

  Acute effect (1 hour post-intervention)

Study Arms (4)

Panel Group

EXPERIMENTAL

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

Device: Panel Effective Photobiomodulation Therapy

Panel Sham Group

SHAM COMPARATOR

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

Device: Sham Panel Photobiomodulation Therapy

Modified ILIB Group

EXPERIMENTAL

Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method

Device: Modified ILIB Photobiomodulation Therapy

Modified ILIB Sham Group

SHAM COMPARATOR

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

Device: Modified ILIB Sham Photobiomodulation Therapy

Interventions

Panel Effective Photobiomodulation Therapy DEVICE

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

Panel Group

Sham Panel Photobiomodulation Therapy DEVICE

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

Panel Sham Group

Modified ILIB Sham Photobiomodulation Therapy DEVICE

ILIB Therapy device turned off for the sham ILIB therapy

Modified ILIB Sham Group

Modified ILIB Photobiomodulation Therapy DEVICE

Common laser used in ILIB mode for modified ILIB therapy

Modified ILIB Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of São Carlos

São Carlos, São Paulo, 13565-905, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, Master's student

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: November 7, 2024
• Study Start: May 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)