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临床试验/NCT06217276
NCT06217276招募中不适用

Examining the Relationship Between Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation in Chronic Obstructive Pulmonary Disease Patients.

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Lower extremity muscle oxygenation level measurement

研究概览

简要总结

In our study, changes in vastus lateralis muscle oxygenation will be evaluated with the Moxy device, a functional infrared oxygen measurement device, during the inspiratory muscle fatigue protocol in COPD cases and the healthy control group.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a diagnosis of Stage 2-3 COPD according to the following clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS).
  • Having been using the same medications for the last 4 weeks

排除标准

  • Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and requiring high-flow oxygen therapy (˃ 3-4 L\min).
  • Presence of any vascular problem that may affect lower extremity muscle oxygenation
  • Presence of another respiratory system disease other than COPD
  • Patients who have had an acute COPD exacerbation in the last 4 weeks
  • Patients experiencing COPD exacerbations during the study protocol
  • Presence of fatty tissue or scar tissue at the measurement points, which may impair the measurement quality.
  • Have already participated in another clinical trial within the last 30 days that may affect the results of the study.
  • Inclusion Criteria for Healthy Cases
  • Being over 18 years of age
  • Not having any diagnosed chronic disease
  • Not being a smoker

结局指标

主要结局

Lower extremity muscle oxygenation level measurement

时间窗: 20 minutes

Near Infrared Reflection Spectroscopy device will be used. The device measures and monitors muscle oxygen by taking the reflected rays of infrared rays given to the body from two different sensors to measure muscle oxygenation levels in muscle tissue. The measurement will be made in the dominant lower extremity, and the device will be placed in the mid-thigh region at the distance between the spina iliaca anterior superior reference point and the midpoint of the patella.

Lower extremity muscle total hemoglobin amount level measurement

时间窗: 20 minutes

Near Infrared Reflection Spectroscopy device will be used. The device measures and monitors muscle total hemoglobin amount by taking the reflected rays of infrared rays given to the body from two different sensors to measure muscle oxygenation levels in muscle tissue. The measurement will be made in the dominant lower extremity, and the device will be placed in the mid-thigh region at the distance between the spina iliaca anterior superior reference point and the midpoint of the patella.

次要结局

  • Peripheral oxygen saturation measurement(20 minutes)
  • Forced vital capacity (FVC),(5 minutes)
  • Forced expiratory volum in one second (FEV1)(5 minutes)
  • Respiratory muscle strength(10 minutes)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

esra pehlivan

Principal Investigator

Saglik Bilimleri Universitesi

研究点 (2)

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