NCT06678698Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 13 Oct 2024
- Start date
- 1 May 2024
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- Universidade Federal de Sao Carlos
- Diseases
- High blood pressure
- NCT number
- NCT06678698
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 1 May 2024 to the primary completion date, 30 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Photosensitive drugs use
Other illness
- Diabetes diagnosis
- 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 epilepsy or seizures
Other
- Smokers
- BMI \> 30 kg/m²
- 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)
- Pregnant women or under suspicion
- Participants who present a systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg on the day of the intervention
Who the study is looking for
- 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
Age in the registry: 40 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federal University of São Carlos Coordinator of this site? Confirm its status | São Carlos | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.