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临床试验/NCT01078883
NCT01078883Unknown不适用

Association Between Respiratory Muscle Performance and Functional Capacity in Patients With Primary Stage IIIb & IV Lung Cancer

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
1-year respiratory morbidity rate and 1-year mortality rate

研究概览

简要总结

The purpose of our study is to investigate the association between respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory morbidity rate, and 1-year mortality in patients with primary stage IIIb and IV lung cancer.

详细描述

Background and Purpose: Respiratory muscle function is important in sustaining the levels of physical activity required for daily life. The purpose of our study is to investigate the association between respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory morbidity rate, and 1-year mortality in patients with primary stage IIIb and IV lung cancer.

Methods: A total of 120 patients with newly diagnosed primary stage IIIb and IV lung cancer will be recruited from the National Taiwan University Hospital. Demographic and clinical signs/syndromes will be obtained from the chart. Pain and dyspnea will be measured using visual analog scale. Respiratory muscle strength will be tested by measuring maximal inspiratory and expiratory pressure (PImax and PEmax, respectively). Spirometric variables, forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) will be measured. Functional capacity will be measured using Karnofsky performance status and Simmonds functional assessment. Anxiety/depression symptom will be measured using Hospital Anxiety and Depression Scale. One year respiratory complication morbidity and 1-year mortality will be recorded in prospective nature. Spearman's and Pearson correlation coefficient will be used to test the relationship between respiratory muscle performance and multiple variables. Univariate and stepwise multiple regression analyses will be used to identify factors associated with respiratory muscle performance, functional capacity, one-year respiratory morbidity and one-year mortality rate in patients with primary stage IIIb and IV lung cancer.

Clinical relevance: The prevalence of lung cancer is increasing in the recent years. The attempt to understand the relations between respiratory muscle performance, functional capacity and associated clinical courses will shed light on whether chest physical therapy intervention will be beneficial for patients with primary IIIb and IV lung cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of stage IIIb/V lung cancer
  • Normal cognition (a Mini Mental State Examination score of more than/equal to 24 points)
  • Able to finish all tests

排除标准

  • A clinical diagnosis affecting respiratory muscle function and functional activity performance (e.g. acute pneumonia)

结局指标

主要结局

1-year respiratory morbidity rate and 1-year mortality rate

时间窗: 1 year

次要结局

  • respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom(1-2 days)

研究者

申办方类型
Other

研究点 (1)

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