Acute Effect of Photobiomodulation in Individuals with Hypertension
Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial
Universidade Federal de Sao Carlos
48 participants
May 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria13
- 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
Interventions
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
Use of common red lamp to perform the sham photobiomodulation for the panel group
ILIB Therapy device turned off for the sham ILIB therapy
Common laser used in ILIB mode for modified ILIB therapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06678698