Hypertension
Conditions
Keywords
hypertension, photobiomodulation, low-level light therapy
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.
Interventions
DEVICEPanel 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
DEVICESham Panel Photobiomodulation Therapy
Use of common red lamp to perform the sham photobiomodulation for the panel group
DEVICEModified ILIB Sham Photobiomodulation Therapy
ILIB Therapy device turned off for the sham ILIB therapy
DEVICEModified ILIB Photobiomodulation Therapy
Common laser used in ILIB mode for modified ILIB therapy
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Universidade Federal de Sao Carlos
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure | Acute effect (immediately post-intervention until 24 hours after) | Diastolic blood pressure measured in millimeters of mercury (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed