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临床试验/NCT05296707
NCT05296707已完成不适用

Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma

Ege University2 个研究点 分布在 2 个国家目标入组 105 人开始时间: 2019年3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
105
试验地点
2
主要终点
Inflammatory marker

研究概览

简要总结

As inflammation and oxidative stress increase in asthma patients, the severity of symptoms and clinical findings increase. Therefore, this study was planned to evaluate the possible effect of inspiratory muscle training (IMT) on inflammation markers and oxidative stress in childhood asthma.

The study included asthma patient; 35 routine medication, 35 drug therapy and inspiratory muscle training (IMT), and 35 healthy total 105 children aged 8-17 years. Demographic information and hemogram values were recorded. Functional capacity was evaluated with the 6-minute walking test, quality of life PedsQL, respiratory muscle strength oral pressure measuring device, respiratory function test, dyspnea severity with Modified Borg Scale. C-Reactive Protein (CRP), Periostin, Transforming Growth Factor-βeta (TGF-β), Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Oxidative Stress Index (OSI) were analyzed. IMT was given with a Threshold IMT device for 7 days/6 weeks at 30% of maximal inspiratory pressure, and then a second evaluation was made.

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
None

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Have been diagnosed with asthma,
  • Between the ages of 8-17,
  • No asthma attack,
  • Cooperating with the study,
  • Without cerebral palsy, mental retardation or any other major neurological diagnosis,
  • Agreeing to participate in the study,
  • Cases whose medication has not been changed for at least three weeks.

排除标准

  • Presence of kyphoscoliosis that may affect respiration,
  • Having advanced postural alignment problem,
  • Having mental problems,
  • Having neuromuscular disease,
  • Making changes in the medications used in the last three weeks,
  • Presence of inflammatory diseases such as juvenile idiopathic arthritis.

研究组 & 干预措施

Inspiratory muscle training group

Experimental

Threshold IMT was given this group. Applied for 7 days 6 weeks.

干预措施: Inspiratory muscle training (Other)

Inspiratory muscle training group

Experimental

Threshold IMT was given this group. Applied for 7 days 6 weeks.

干预措施: Used routine medicine (Other)

Used routine medicine group

Active Comparator

Followed 6 weeks

干预措施: Used routine medicine (Other)

Control Group

Active Comparator

Health children

干预措施: Control group (Other)

结局指标

主要结局

Inflammatory marker

时间窗: 6 weeks

We assessed C reaktive protein from Blood sample

Oxidative stress

时间窗: 6 weeks

We assessed Total oxidative level.

次要结局

  • functional capacity(6 weeks)
  • Quality life(6 weeks)
  • Pulmonary function test(6 weeks)
  • Respiratory muscle strength(6 weeks)

研究者

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

Ozden Gokcek

Principal Investigator

Ege University

研究点 (2)

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