Clinical trial NCT06678698: Acute Effect of Photobiomodulation in Individuals with Hypertension
Official title: Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
photobiomodulation
low-level light therapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-11-07
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diastolic Blood Pressure
timeFrame: Acute effect (immediately post-intervention until 24 hours after)
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: Acute effect (immediately post-intervention until 24 hours after)
measure: Mean Arterial Pressure
timeFrame: Acute effect (immediately post-intervention until 24 hours after)
measure: Endothelial Function
timeFrame: Acute effect (About 25 minutes post-intervention)
measure: Arterial Stiffness
timeFrame: Acute effect (About 15 minutes post-intervention)
measure: Blood Nitrite
timeFrame: Acute effect (1 hour post-intervention)
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos
state: São Paulo
Study officials:
References: