Effectiveness of Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Measure of functional capacity
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is among the most common chronic respiratory diseases (CKD). Millions of people of all ages suffer from these diseases. COPD is between the fifth and sixth of the leading causes of death in Brazil. It generates an inflammatory pulmonary response that is softened by non-curative treatments and that present serious side effects. Low intensity laser (LBI) or laser therapy has been used for about 50 years to help the healing process, revealing efficient anti-inflammatory and analgesic responses, as well as experimental models of acute and chronic inflammation. However, little is known about its response in inflammatory lung diseases, especially COPD. Some reports indicate that laser therapy may interfere positively by relieving clinical signs, the onset, and the final symptoms of pulmonary inflammation. The present project aims to study the effects of LBI on Chronic Obstructive Pulmonary Disease in patients with pulmonary processes, determine their mechanisms of action and evaluate its effect on patients' functional capacity.
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
- Single (Participant)
盲法说明
the participant will be randomized through a raffle without knowing which group has the active intervention or placebo.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes;
- •Over 18 years of age;
- •With a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 2 years according to the criteria of the clinically stable Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), free of disease exacerbation in the last 30 days;
- •Performing routine outpatient treatment with a pulmonologist;
- •Agreement to participate.
排除标准
- •Individuals with other comorbidities, such as: Acute Lung Disease, Congestive Heart Failure, Liver Failure, Pulmonary Thromboembolism, Acute Respiratory Distress Syndrome, Neoplasms, HIV Positive, Immunodeficiency, Blood Disorders, Septicemia or recent major surgery.
- •Patients with cystic fibrosis and Kartagner's syndrome.
研究组 & 干预措施
Control group
干预措施: Placebo group (Procedure)
Laser group
干预措施: Low level laser therapy (Radiation)
结局指标
主要结局
Measure of functional capacity
时间窗: 4 weeks
Walk test: In a flat hallway, it will be delimited by two cones and the patient will be guided to walk from one side to the other. The walking speed will be controlled by a "compact disc" that emits beeps (simple BIP) at regular intervals. The test will be interrupted by exhaustion or when the patient is unable to maintain the proposed speed.
次要结局
- TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-10 e IFN-α(4 weeks)
- Spirometry(4 weeks)
- Quality of life assessment questionnaire(4 weeks)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho