Effect of Vascular Photobiomodulation on Cardiovascular Parameters of Treated Hypertensive Patients: A Randomized and Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Brachial Artery Vascular Function
研究概览
简要总结
This double-blind, randomized, sham-controlled clinical trial aims to evaluate the effects of vascular photobiomodulation on blood pressure and vascular function in hypertensive patients treated with losartan. A total of 80 patients using losartan (100 mg/day for at least two months) will be recruited and followed for 4 weeks. Participants will be randomly allocated to either an active photobiomodulation group or a sham control group.
详细描述
This is a double-blind, parallel-group, randomized, sham-controlled clinical trial. A total of 80 hypertensive patients under stable treatment with losartan (100 mg/day for at least two months) will be recruited and randomly allocated (1:1) to one of the following groups:
- Photobiomodulation Group;
- Sham Control Group.
The intervention will last 4 weeks, with two sessions per week, totaling 8 sessions. Each session will last 30 minutes.
The photobiomodulation intervention will consist of laser irradiation applied over the radial artery using a red laser (wavelength: 660 nm; power: 100 mW; duration: 30 minutes per session; total energy: 180 J per session). The sham group will undergo an identical procedure; however, the laser emission will be blocked to ensure no therapeutic effect. Blinding will be maintained for all participants and outcome assessors, with only the technician responsible for device setup aware of group allocation.
Assessments will be conducted at the following time points:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be taking losartan at a dose of 100 mg/day, either as monotherapy or in combination with other antihypertensive medications, administered in two divided doses, for a minimum of 2 months and a maximum of 24 months.
- •Present systolic blood pressure is less than or equal to 140 mmHg and diastolic less than or equal to 90 mmHg.
- •Not having used any other antihypertensive medication in the last 2 months.
- •Age between 18 and 65 years
- •If female, not pregnant
- •No cutaneous/subcutaneous lesions on both arms.
- •No musculoskeletal, rheumatic, cardiovascular, metabolic, neurological, oncological, immunological, hematological, psychiatric or cognitive diagnoses and that may be worsened by the intervention or prevent the correct application of FBM vascular.
排除标准
- •Changes in medication status during the study
研究组 & 干预措施
Sham Photobiomodulation
Participants will undergo an identical procedure to the experimental group; however, the laser emission will be blocked to ensure no therapeutic effect. All procedures, duration, and frequency will be identical to the experimental group to maintain blinding.
干预措施: Sham Photobiomodulation (Device)
Photobiomodulation
Participants will receive vascular photobiomodulation therapy applied over the radial artery using a red laser (wavelength: 660 nm; power: 100 mW). Each session will last 30 minutes, with a total energy delivery of 180 J per session. Sessions will be performed twice per week for 4 weeks.
干预措施: Vascular Photobiomodulation (Device)
结局指标
主要结局
Change in Brachial Artery Vascular Function
时间窗: Baseline and 4 weeks
Flow-mediated dilation (FMD, %) of the brachial artery assessed by Doppler ultrasound. Higher values indicate better endothelial function
次要结局
- Change in Resting Systolic and Diastolic Blood Pressure(Baseline and 4 weeks)
- Acute Change in Brachial Artery Vascular Function(Baseline and 4 weeks)
- Acute Change in Resting Blood Pressure(Baseline and 4 weeks)
- Change in Residential Blood Pressure(Baseline and 4 weeks)
- Change in Resting Heart Rate(Baseline and 4 weeks)
研究者
Raphael Mendes Ritti Dias
Professor
University of Nove de Julho