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临床试验/NCT04929990
NCT04929990已完成不适用

The Therapeutic Effect of Inspiratory and Expiratory Muscle Strengthening Training on Patients With COPD and Mild Cognitive Impairment

Taichung Veterans General Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年8月7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
70
试验地点
2
主要终点
MMSE

研究概览

简要总结

Patients with COPD and MCI received either inspiratory muscle training or inspiratory plus expiratory muscle training and compared the therapeutic effects

详细描述

Patients with COPD and MCI were recruited, and were randomly assigned to the experimental group and the control group. The experimental group consisted of EMT and IMT for a total of 8 weeks, while the control group received IMT only. Outcomes measured and compared in this cohort were diaphragmatic thickness fraction and excursion examined by ultrasound, the dyspnea score of modified Medical Research Council (mMRC), the cognitive score of Mini-Mental State Examination (MMSE), and the score of COPD Assessment Test (CAT). In addition, the pulmonary function test, the cardiopulmonary exercise test, and the physiology performance of six minute walking test were also obtained. We also analyzed the difference of each parameters before and after training in each patient.

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

性别
All
接受健康志愿者

入选标准

  • Having definite diagnosis of COPD, namely the value of the FEV1 divided by forced vital capacity (FVC) 10 to 15 minutes after beta-2 agonist inhalation being less than 0.
  • The score of Mini-Mental State Examination (MMSE) being between 23 and 27

排除标准

  • Being not able to follow instructions on respiratory muscle training or complete the questionnaires of our study due to cognitive impairment.
  • Having difficulty to complete the cardiopulmonary exercise testing or the six minute walking test (6MWT) due to high risk cardiopulmonary diseases or other orthopedic conditions.
  • Having the diagnosis of lung cancer or history of receiving thoracoabdominal surgery
  • Having Body Mass Index more than 30

结局指标

主要结局

MMSE

时间窗: 8 weeks

Mini-Mental State Examination

次要结局

  • Diaphragmatic excursion(8 weeks)
  • Diaphragmatic thickness fraction(8 weeks)
  • the distance walked in 6 minutes(8 weeks)
  • chronic obstructive pulmonary disease assessment test (CAT)(8 weeks)
  • diffusing capacity of the lung for carbon monoxide (DLCO)(8 weeks)
  • dead space fraction (Vd/Vt)(8 weeks)
  • forced expiratory volume in 1 second divided by forced vital capacity(8 weeks)
  • DLCO divided by alveolar volume (VA)(8 weeks)
  • the change of Borg scale in 6 minutes walking test(8 weeks)
  • forced vital capacity(8 weeks)
  • forced expiratory volume in 1 second(8 weeks)
  • modified Medical Research Council (mMRC)(8 weeks)
  • the change of oxygen saturation in 6 minutes walking test(8 weeks)
  • minute ventilation to carbon dioxide output (VE/VCO2) slope(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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