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临床试验/NCT01448564
NCT01448564Unknown不适用

Effects of Light-emitting Diodes (LED) on Peripheral Muscle Function, Exercise Tolerance and Cardiorespiratory Response During Exercise in Patients With Chronic Obstructive Pulmonary Disease

Eduardo Foschini Miranda1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
27
试验地点
1
主要终点
Analysis of the recovery time for the isometric and dynamic protocol

研究概览

简要总结

Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue. The objective of this study is to assess the acute effects of LEDs on muscle function, exercise capacity, and cardiorespiratory responses during isometric and dynamic exercise in patients with COPD. This study will assess 30 patients with moderate to severe obstruction (FEV1 ≤ 70% predicted). Isometric and dynamic protocols will be conducted in two visits each, for a total of four visits a week a part. First, a venous blood sample will be taken from the patients. The isometric protocol will start with the determination of the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC) for the isometric endurance test (IET). Patients will be randomized to receive either the placebo or LED application. Immediately after finishing this procedure, the patients will carry out the IET until the limit of tolerance or until a 20% fall of strength is observed. After the test, another blood sample will be taken. In the other visit (one week later), the same order of procedures will be performed, except with the opposite (LED or placebo). For the dynamic protocol, the same procedures described above will be followed except with the maximal incremental cycle ergometer test used instead of the IET. The electromyography will be recorded during the isometric and dynamic protocols. Differences in muscle function, exercise capacity, and cardiorespiratory responses between the LED and placebo applications will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients with COPD by increasing exercise tolerance.

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)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •35 patients will be selected (see sample calculation in Section 6) who have moderate to severe obstruction (FEV1 ≤ 70% predicted) and stable disease, as suggested by the absence of changes in medication in the last 4 weeks.

排除标准

  • •Ischemic heart disease, recent surgery, neuro-muscular or orthopedic that limit the performance of the protocol.
  • •Patients will only be included in the study after signing the consent form.

研究组 & 干预措施

Laser therapy

Active Comparator

Recently has been using the LED, known by its acronym in English LED (Light Emitting Diode), devices that are light-emitting non-coherent and monochromatic, having a longer wavelength (± 10 - 30 nm) compared to lasers. The difference between the fundamental radiation emitted by a laser and an LED is the coherence of the beam.

干预措施: Laser therapy (Other)

Placebo Laser therapy

Placebo Comparator

干预措施: Placebo laser therapy (Other)

结局指标

主要结局

Analysis of the recovery time for the isometric and dynamic protocol

时间窗: Measures muscular endurance will be compared after a period of 1 week.

次要结局

  • Analysis of lactate levels and the activity of CK and C-reactive protein (CRP).(Measures blood will be compared after a period of 1 week.)

研究者

发起方
Eduardo Foschini Miranda
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eduardo Foschini Miranda

Principal Investigator

University of Nove de Julho

研究点 (1)

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