Acute Effect of Photobiomodulation in Individuals with Hypertension
- Conditions
- Hypertension
- Registration Number
- NCT06678698
- Lead Sponsor
- Universidade Federal de Sao Carlos
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Diastolic Blood Pressure Acute effect (immediately post-intervention until 24 hours after) Diastolic blood pressure measured in millimeters of mercury (mmHg)
- Secondary Outcome Measures
Name Time Method Systolic Blood Pressure Acute effect (immediately post-intervention until 24 hours after) systolic blood pressure measured in millimeters of mercury (mmHg)
Mean Arterial Pressure Acute effect (immediately post-intervention until 24 hours after) mean arterial pressure measured in millimeters of mercury (mmHg)
Endothelial Function Acute effect (About 25 minutes post-intervention) Endothelial function measured by flow-mediated dilation, with a brachial artery ultrasound
Arterial Stiffness Acute effect (About 15 minutes post-intervention) Arterial stiffness measured by pulse wave velocity
Blood Nitrite Acute effect (1 hour post-intervention) Blood nitrite levels
Trial Locations
- Locations (1)
Federal University of São Carlos
🇧🇷São Carlos, São Paulo, Brazil