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NCT Number: NCT06678698

Acute Effect of Photobiomodulation in Individuals with Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location status: Recruiting

Location contact

Lara Espósito, PT

CONTACT

[email protected]

+551633518985

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sham Panel Photobiomodulation Therapy

Device

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

Modified ILIB Sham Photobiomodulation Therapy

Device

ILIB Therapy device turned off for the sham ILIB therapy

Modified ILIB Photobiomodulation Therapy

Device

Common laser used in ILIB mode for modified ILIB therapy

Primary outcomes

  1. Diastolic Blood Pressure

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

    Diastolic blood pressure measured in millimeters of mercury (mmHg)

Secondary outcomes

  1. Systolic Blood Pressure

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

    systolic blood pressure measured in millimeters of mercury (mmHg)

  2. Mean Arterial Pressure

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

    mean arterial pressure measured in millimeters of mercury (mmHg)

  3. Endothelial Function

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

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

  4. Arterial Stiffness

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

    Arterial stiffness measured by pulse wave velocity

  5. Blood Nitrite

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

    Blood nitrite levels

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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