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临床试验/NCT03737630
NCT03737630已完成不适用

Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis

Universidade Federal do Rio Grande do Norte1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年8月5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
10
试验地点
1
主要终点
Change from baseline Posture at 4 weeks

研究概览

简要总结

Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. With the evolution of the condition, secondary complications arise, such as postural changes, decreased respiratory muscle strength, decreased functional capacity and, consequently, quality of life. Therefore, respiratory muscle training may be an intervention that improves the respiratory condition of these individuals, allowing an improvement in the quality of life and may delay the evolution of respiratory symptoms. Thus, this study aims to investigate a home protocol of respiratory muscle training on respiratory muscle strength, lung function, quality of life, posture and functional capacity in adolescents and adults with cystic fibrosis. The researchers believe that the training can cause an improvement in the studied variables, and can be inserted in the usual treatment of these patients.

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, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of cystic fibrosis, confirmed by the sweat test;
  • 14 - 25 years;
  • Clinical stability;
  • Absence of bacterial colonization for 4 weeks;
  • Both sexes;

排除标准

  • Inability to perform the protocol established by the study;
  • Present any intercurrence during data collection;
  • Being unable to understand and / or perform procedures.
  • Colonization during study participation;
  • Patient hospitalization due to worsening of the clinical picture.

结局指标

主要结局

Change from baseline Posture at 4 weeks

时间窗: Baseline and after 4 weeks of training

Inclinometer Danoplus®

Change from baseline Health-related quality of life at 4 weeks

时间窗: Baseline and after 4 weeks of training

Health-related quality of life questionnaire (HRQoL)

次要结局

  • Change from baseline Pulmonary function at 4 weeks(Baseline and after 4 weeks of training)
  • Change from baseline Respiratory muscle strength at 4 weeks(Baseline and after 4 weeks of training)
  • Change from baseline Functional capacity at 4 weeks(Baseline and after 4 weeks of training)

研究者

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

Patri-cia Angelica de Miranda Silva Nogueira

PhD

Universidade Federal do Rio Grande do Norte

研究点 (1)

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