Acute Effect of Photobiomodulation in Individuals with Hypertension
ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorUniversidade Federal de Sao Carlos
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diabetes diagnosis
Smokers
BMI > 30 kg/m²
Cardiac pacemaker use
Trial design
Design model
Factorial
Treatments tested in this trial
Panel Effective Photobiomodulation Therapy
DevicePhotobiomodulation 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
Sham Panel Photobiomodulation Therapy
DeviceUse of common red lamp to perform the sham photobiomodulation for the panel group
Modified ILIB Sham Photobiomodulation Therapy
DeviceILIB Therapy device turned off for the sham ILIB therapy
Modified ILIB Photobiomodulation Therapy
DeviceCommon laser used in ILIB mode for modified ILIB therapy
Treatment groups
48 Participants
are divided into 4 treatment groupsGroup A: Panel GroupExperimental treatment 1 intervention
Group B: Panel Sham GroupSham comparator 1 intervention
Group C: Modified ILIB GroupExperimental treatment 1 intervention
Group D: Modified ILIB Sham GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diastolic Blood Pressure
Diastolic blood pressure measured in millimeters of mercury (mmHg)
Time frame
Acute effect (immediately post-intervention until 24 hours after)Secondary outcomes
1
Systolic Blood Pressure
systolic blood pressure measured in millimeters of mercury (mmHg)
Time frame
Acute effect (immediately post-intervention until 24 hours after)2
Mean Arterial Pressure
mean arterial pressure measured in millimeters of mercury (mmHg)
Time frame
Acute effect (immediately post-intervention until 24 hours after)3
Endothelial Function
Endothelial function measured by flow-mediated dilation, with a brachial artery ultrasound
Time frame
Acute effect (About 25 minutes post-intervention)4
Arterial Stiffness
Arterial stiffness measured by pulse wave velocity
Time frame
Acute effect (About 15 minutes post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade Federal de Sao Carlos
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
Source ClinicalTrials.gov