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临床试验/NCT03041155
NCT03041155已完成不适用

Respiratory Muscle Training in Hemodialysis Patients: Effects on Physiologic Parameters and Endothelium-related Biomarkers

Universidade Federal do Ceara2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年2月1日最近更新:
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
48
试验地点
2
主要终点
endothelium glycocalyx biomarkers

研究概览

简要总结

The research protocol is a Randomized Clinical Trial that has the effectiveness of a given respiratory muscle training protocol over the indicative variables: Pulmonary function; Markers of oxidative stress and inflammation, endothelial markers and Quality of life in patients with chronic kidney disease undergoing hemodialysis. According to the Investigators, this topic was proposed since it is known that several pulmonary complications occur as a consequence of chronic kidney disease due to uremic myopathy. Therefore, the hypothesis is that the application of a respiratory muscle training protocol will contribute positively pulmonary functionality and a decrease in oxidative stress and inflammation in chronic kidney patients, consequently, will bring improvement in the quality of life for these patients. The Patients will be divided into two groups: control group - No intervention of the Muscular Training (CG) And Intervention Group (GI). The intervention protocol will be composed of respiratory muscle training And lasts for two (2) months, with three (3) visits per week. It will be carried out through Threshold PeP appliance. The twelve (12) first training sessions will have a total duration of 30 minutes 15 minutes with inspiratory load of 20 cmH2O and 15 minutes with expiratory load of 20 CmH 2 O; and the others (12) twelve sessions will last 40 minutes each, with 20 minutes with an inspiratory load of 20 CmH2O and 20 minutes with expiratory load of 20 cmH2O. The variables evaluated will be: muscular strength Respiratory (maximum inspiratory pressure and maximum expiratory pressure - Pimáx and Pemáx); Lung function (Slow Vital Capacity - CVL, forced expiratory volume in the first minute - VEF1, Vital Capacity Forced - CVF and Maximum Voluntary Ventilation - VVM); Serum levels of oxidative stress markers, endothelial markers and endothelin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Maintenance hemodialysis for more than 3 months
  • No COPD diagnosis

排除标准

  • Decompensated Heart failure
  • Acute coronary disease in the last 3 months
  • Active infection

研究组 & 干预措施

treatment

Experimental

Muscle respiratory training

干预措施: Muscle respiratory training (Behavioral)

control

No Intervention

No intervention

结局指标

主要结局

endothelium glycocalyx biomarkers

时间窗: 8 weeks

plasma syndecan-1 (ng/mL)

次要结局

  • Oxidative stress(8 weeks)
  • Mean blood pressure(8 weeks)
  • Endothelium biomarker(8 weeks)
  • Endotehlium Biomarker(8 weeks)
  • Aberrant angiogenesis(8 weeks)

研究者

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

Alexandre Braga Liborio

Visitant Professor

Universidade Federal do Ceara

研究点 (2)

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