Acute Effect of Photobiomodulation in Individuals with Hypertension

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство Sham Panel Photobiomodulation Therapy
  Use of common red lamp to perform the sham photobiomodulation for the panel group
• Устройство Modified ILIB Sham Photobiomodulation Therapy
  ILIB Therapy device turned off for the sham ILIB therapy
• Устройство Modified ILIB Photobiomodulation Therapy
  Common laser used in ILIB mode for modified ILIB therapy

Первичные конечные точки

• Diastolic Blood Pressure [Срок оценки: Acute effect (immediately post-intervention until 24 hours after)]

Вторичные конечные точки (5)

• Systolic Blood Pressure [Срок оценки: Acute effect (immediately post-intervention until 24 hours after)]
• Mean Arterial Pressure [Срок оценки: Acute effect (immediately post-intervention until 24 hours after)]
• Endothelial Function [Срок оценки: Acute effect (About 25 minutes post-intervention)]
• Arterial Stiffness [Срок оценки: Acute effect (About 15 minutes post-intervention)]
• Blood Nitrite [Срок оценки: Acute effect (1 hour post-intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Federal University of São Carlos — São Carlos

Идентификаторы

NCT: NCT06678698 · UFSaoCarlosPBM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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