Acute Effect of Photobiomodulation in Individuals with Hypertension
Recruiting · NCT06678698 · Interventional (participants receive a specific treatment) · Lead sponsor: Universidade Federal de Sao Carlos
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Federal University of São Carlos - São Carlos, São Paulo, Brazil