Acute Effect of Photobiomodulation on Blood Pressure, Endothelial Function and Arterial Stiffness in Individuals with Hypertension: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Diastolic Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diabetes diagnosis
- •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
结局指标
主要结局
Diastolic Blood Pressure
时间窗: Acute effect (immediately post-intervention until 24 hours after)
Diastolic blood pressure measured in millimeters of mercury (mmHg)
次要结局
- Systolic Blood Pressure(Acute effect (immediately post-intervention until 24 hours after))
- Mean Arterial Pressure(Acute effect (immediately post-intervention until 24 hours after))
- Endothelial Function(Acute effect (About 25 minutes post-intervention))
- Arterial Stiffness(Acute effect (About 15 minutes post-intervention))
- Blood Nitrite(Acute effect (1 hour post-intervention))
研究者
Lara Maria Bataglia Espósito
Physical Therapist, Master's student
Universidade Federal de Sao Carlos