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临床试验/NCT03639220
NCT03639220已完成不适用

Photobiomodulation Therapy Combining Laser Diodes, Light-emitting Diodes in Exercise Capacity Assessed by 6MST in Patients With COPD - A Crossover, Randomized, Triple-blinded, Placebo-controlled Clinical Trial

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
The primary outcomes are oxygen uptake

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is characterized by dyspnea, as well as musculoskeletal and systemic manifestations. Photobiomodulation therapy (PBMT) with use of low-level laser therapy (LLLT) and/or light emitting diode therapy (LEDT) is an electrophysical intervention that has been found to minimize or delay muscle fatigue. The aim of this study is to evaluate the acute effect of PBMT with combined use of lasers diodes, light emitting diodes (LEDs), on muscle performance, exercise tolerance and metabolic variables during the 6-minute stepper test (6MST) in patients with COPD. Twenty-one patients with COPD will completed the 6MST protocol over 2 weeks, with 1 session per week. PBMT or placebo (PL) will be performed before each 6MST (17 sites on each lower limb, with a dose of 30 J per site, using a cluster of 12 diodes: 4 × 905 nm super-pulsed laser diodes, 4 × 875 nm infrared LEDs, and 4 × 640 nm red LEDs; Multi Radiance Medical™, Solon - OH, USA). Patients will be randomized into two groups before the test according to the treatment they will receive. Assessments will be performed before the start of each protocol. The primary outcomes are oxygen uptake and number of steps, and the secondary outcome are perceived exertion (dyspnea and fatigue in the lower limbs).

详细描述

All patients will have a diagnosis of COPD according to the global initiative for chronic obstructive lung disease (GOLD) criteria. The patients will be at a stable phase of the disease, indicated by a lack of change in medical therapy (including oral steroids) or an exacerbation of symptoms in the preceding 4 weeks. Patients with other known severe chronic diseases, including cardiac, neuromuscular, or orthopedic disorders, will be excluded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

A participating researcher who programmed the PBMT device (Multi Radiance Medical™, Solon, OH) based on the randomization results performed the randomization. He will be instructed not to inform the participants or other researchers of the PBMT dose (active or placebo). Thus, the researcher who performed the PBMT will be blinded to the dose administered to the participants. To further maintain blinding, participants used opaque goggles to prevent them from seeing whether a light will be irradiated.

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD patients
  • Patients are at a stable phase of the disease

排除标准

  • Patients with cardiac diseases
  • Neuromuscular diseases
  • Orthopedic disorders

结局指标

主要结局

The primary outcomes are oxygen uptake

时间窗: 1 week

The 6MST aims to measure the oxygen uptake performed on a stepper in 6 minutes. During the 6MST, the rates of oxygen consumption (VO2) will be measured using a gas analyzer.

次要结局

  • The secondary outcomes are number of steps(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ernesto Cesar Pinto Leal Junior

Full professor

University of Nove de Julho

研究点 (2)

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