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临床试验/NCT00874965
NCT00874965已完成不适用

Study of the Benefits of Lower Limb Electrostimulation Training on Muscular Parameters and Minute Ventilation During Exercise in Severe and Deconditioned COPD Patients.

Laval University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Change in the strength of the quadriceps over the 6-week electrostimulation program.

研究概览

简要总结

This study was designed to test the following hypothesis:

The benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in COPD patients

详细描述

Background: Because it has little impact on ventilatory requirements and dyspnea, muscle electrostimulation appears as a promising alternative to general physical reconditioning in advanced COPD and its feasibility has been confirmed in this population. However, the physiological mechanisms underlying the proposed benefits of electrostimulation training have not been explored.

Objective

To evaluate in COPD patients the physiological mechanisms of changes in exercise tolerance after electrostimulation training.

Method: We propose to conduct a controlled, randomized and double blind clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 24 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Before and after training, patients perform endurance shuttle walking test, muscle function testing, muscle biopsy, blood sampling and health-related quality of life questionnaire.

Planning analysis: The main outcome will be change in the strength of the quadriceps over the 6-week electrostimulation program. The other end-points will be mid-thigh and calf muscle cross-sectional area, lower limb muscle endurance, ventilation, dyspnea, leg fatigue, operational lung volumes at iso-time and walking time during an endurance shuttle walk, muscle hypertrophying/atrophying pathways and muscle aerobic capacity. For each group, pre- and post-training comparisons will be made using a repeated measures design. The magnitude of the pre- and post-training changes will also compared between both groups with a two-way ANOVA (group, training effect) with repeated measures on the second factor (training effect). A p value < 0.05 will be considered statistically significant.

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, Investigator)

入排标准

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

入选标准

  • FEV1 < 60% predicted value and FEV1/ FVC < 70%
  • 6-minute walking distance < 400 m

排除标准

  • Patients suffering from cardiovascular, neurological, skeletal muscle, or any other condition that could alter their capacity to perform the exercise test
  • Patients taking systemic corticosteroids on a daily basis (patients having received systemic steroids for the treatment of up to two exacerbations in the preceding year and those on inhaled steroids will be allowed)
  • Patients with room air PaO2 < 60 mm Hg will be excluded.

结局指标

主要结局

Change in the strength of the quadriceps over the 6-week electrostimulation program.

时间窗: 6 to 8 weeks

次要结局

  • Ventilation at iso-time during an endurance shuttle walkMuscle(6 to 8 weeks)
  • hypertrophying/atrophying pathways(6 to 8 weeks)
  • Muscle aerobic capacity: fibre-typing, oxydative enzymes, muscle capillarization(6 to 8 weeks)

研究者

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

Marthe Bélanger

Professionnel de recherche

Laval University

研究点 (2)

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