Acute Effect of Photobiomodulation in Individuals with Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Panel Effective Photobiomodulation Therapy, Sham Panel Photobiomodulation Therapy, Modified ILIB Sham Photobiomodulation Therapy, Modified ILIB Photobiomodulation Therapy.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: 40 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial
Overview
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.
Interventions
- Device 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 - Device Sham Panel Photobiomodulation Therapy
Use of common red lamp to perform the sham photobiomodulation for the panel group - Device Modified ILIB Sham Photobiomodulation Therapy
ILIB Therapy device turned off for the sham ILIB therapy - Device Modified ILIB Photobiomodulation Therapy
Common laser used in ILIB mode for modified ILIB therapy
Primary outcome measures
- Diastolic Blood Pressure [Time frame: Acute effect (immediately post-intervention until 24 hours after)]
Secondary outcome measures (5)
- Systolic Blood Pressure [Time frame: Acute effect (immediately post-intervention until 24 hours after)]
- Mean Arterial Pressure [Time frame: Acute effect (immediately post-intervention until 24 hours after)]
- Endothelial Function [Time frame: Acute effect (About 25 minutes post-intervention)]
- Arterial Stiffness [Time frame: Acute effect (About 15 minutes post-intervention)]
- Blood Nitrite [Time frame: Acute effect (1 hour post-intervention)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Federal University of São Carlos — São Carlos
Identifiers
NCT: NCT06678698 · UFSaoCarlosPBM