Actively Recruiting
Acute Effect of Photobiomodulation in Individuals with Hypertension
Led by Universidade Federal de Sao Carlos · Updated on 2024-11-08
48
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
Universidade Federal de Sao Carlos
Lead Sponsor
F
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acute Effect of Photobiomodulation in Individuals with Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sedentary or irregularly inactive individuals
- 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
- Using prescribed hypertension control drugs for at least 3 months
You will not qualify if you...
- Diagnosis of diabetes
- Smoking
- Body mass index greater than 30 kg/m�b2
- Use of cardiac pacemaker
- Presence of arrhythmias or other decompensated cardiovascular diseases
- Musculoskeletal, orthopedic or neurological conditions preventing participation
- Cognitive deficits affecting understanding of assessments
- Active neoplasia, suspicion of neoplasia, or within 5 years in remission
- Large area tattoos or tattoos on the anterior wrist region
- Use of photosensitive drugs
- Pregnancy or suspicion of pregnancy
- Epilepsy or seizures
- Systolic blood pressure ������ 180 mmHg or diastolic blood pressure ���� 110 mmHg on intervention day
AI-Screening
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Trial Site Locations
Total: 1 location
1
Federal University of São Carlos
São Carlos, São Paulo, Brazil, 13565-905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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