Acute Effect of Photobiomodulation in Individuals with Hypertension

NCT ID: NCT06678698

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Panel Group

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

Group Type EXPERIMENTAL

Panel Effective Photobiomodulation Therapy

Intervention Type 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 Sham Group

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

Group Type SHAM_COMPARATOR

Sham Panel Photobiomodulation Therapy

Intervention Type DEVICE

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

Modified ILIB Group

Participants who will receive photobiomodulation irradiation with the transcutaneous ILIB method

Group Type EXPERIMENTAL

Modified ILIB Photobiomodulation Therapy

Intervention Type DEVICE

Common laser used in ILIB mode for modified ILIB therapy

Modified ILIB Sham Group

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

Group Type SHAM_COMPARATOR

Modified ILIB Sham Photobiomodulation Therapy

Intervention Type DEVICE

ILIB Therapy device turned off for the sham ILIB therapy

Interventions

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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

Intervention Type DEVICE

Sham Panel Photobiomodulation Therapy

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

Intervention Type DEVICE

Modified ILIB Sham Photobiomodulation Therapy

ILIB Therapy device turned off for the sham ILIB therapy

Intervention Type DEVICE

Modified ILIB Photobiomodulation Therapy

Common laser used in ILIB mode for modified ILIB therapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role lead

Responsible Party

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Lara Maria Bataglia Espósito

Physical Therapist, Master's student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of São Carlos

São Carlos, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Lara Espósito, PT

Role: primary

+551633518985

Other Identifiers

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UFSaoCarlosPBM

Identifier Type: -

Identifier Source: org_study_id

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