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临床试验/NCT01942889
NCT01942889已完成不适用

Antioxidants Supplementation Associated With Pulmonary Rehabilitation is it Effective on Muscle Dysfunction and Signaling Pathways Involved in the Myopathy of COPD?

University Hospital, Montpellier4 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2012年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
4
主要终点
quadriceps endurance time.Time frame: at the start and the end of the study

研究概览

简要总结

On the basis of published data and investigators results indicating that systemic redox in balance may contribute to the peripheral muscle dysfunction in COPD patients, the investigators propose a study testing the effects of antioxidants and exercise training in COPD patients. The results may have major implication in the improvement of pulmonary rehabilitation benefits

详细描述

COPD will constitute the third cause of mortality in 2012. This chronic respiratory disease is characterized by peripheral dysfunction of skeletal muscle which is associated with major clinical outcomes (prognostics, symptoms, and health related quality of life). Muscle and systemic oxidative stress has been incriminated in this peripheral muscle dysfunction.Exercise training constitute the main validated therapeutic intervention leading to significant muscle function and clinical improvement.Our preliminary results have shown that COPD patients experiment dietary and enzymatic antioxidants defects.Yet, generic antioxidant supplementation has not shown significant muscle function improvement.Therefore, we aim to test the effects of an antioxidant supplementation targeted on the antioxidant defects associated with exercise training on the peripheral muscle function, exercise tolerance and health quality of life in COPD patients.At the cellular level, this muscle dysfunction is related with a fiber atrophy and a metabolic switch (reduce proportion of oxidative fiber).This study will compare the effects of an antioxidant supplementation on the peripheral muscle function and skeletal muscle cellular properties in association with exercise training during a pulmonary rehabilitation course.Volunteers will be randomised in 2 groups: - 1 group treated with the antioxidant supplementation ( 28 days)- 1 group treated with the placeboIntervention will be allocated by chance and a double blind manner. Antioxidant supplementation will associate vitamins and trace elements that won't exceed the maximal nutritional dose recommended.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD patients, 40 years to 78 years, last exacerbation dating at least 4 weeks

排除标准

  • unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
  • nutritional supplementation in the 4 weeks preceding the study (antioxidant, vitamins...)

研究组 & 干预措施

Antioxidant Supplementation

Active Comparator

Vitamin antioxidant and trace elements combination that won't exceed the maximal nutritional dose recommended in France (Vit E, vit C, Selenomethionine, Zinc gluconate).

干预措施: Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program (Dietary Supplement)

Placebo

Placebo Comparator

Placebo

干预措施: Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program (Dietary Supplement)

结局指标

主要结局

quadriceps endurance time.Time frame: at the start and the end of the study

时间窗: up to day 37

sitting on a bench, starting from a 90° knee flexion of the dominant leg, the subjects should perform knee extensions (6 movements per minute) with a workload to 30% of the isometric maximal voluntary contraction until exhaustion. The duration of the test (in seconds) characterizes the quadriceps endurance.

次要结局

  • Isometric maximal voluntary contraction of the quadriceps(up to day 37)
  • muscle and /or serum oxidative stress level(up to day 37)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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