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临床试验/NCT00686660
NCT00686660Unknown不适用

A Multi-Center Study of Rehabilitation to Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)

研究概览

简要总结

This is a multi-center prospective follow-up study.

  • to choose the stable COPD patients in community
  • to compare different modes of exercise (cycling and walking)
  • to compare the effect of different exercises on the quality of life,exercise endurance,dyspnea and depression

详细描述

This is a multi-center prospective follow-up study.More than 20 hospitals participate the research. More than 300 stable COPD patients will be recruited.It is a two-year study. There are four groups, cycling and walking group(C-WG),cycling and non-walking group(C-nonWG),walking and walking group(W-WG),walking and non-walking group(W-nonWG).

  1. All patients from four groups will finish baseline investigation and blood sample, including informed consent,questionaires(SGRQ,CRDQ,MRCQ,Depression Scale,etc.),spirometry,6MWT,MIP,MEP,BMI,CRP,TNF,IL-8, etc.Patients in C-WG and C-nonWG will finish cardiopulmonary test.
  2. Patients receive 8 weeks training program, includes upper and lower extremities endurance exercises and respiratory muscle endurance exercises. Patients in both CGs cycling at cycle ergometry. Patients in W-WG and W-nonWG walking instead. All patients receive training program twice per year, for two years. Patients were supervised by physicians or nurses at hospital while they are training.
  3. In the non-training period, patients in W-WG and C-WG will continue to walk at community, supervised by nurses who call them every month. The other two groups(C-nonWG and W-nonWG) do not receive special requirement on exercise.
  4. Telephone call interview will give to patients every month to find whether they have acute exacerbation. Patients are asked to record their activities during daytime in the diary cards.
  5. All patients will finish investigation and blood sample after one year and two year,including questionaires,spirometry,6MWT,MIP,MEP,BMI,CRP,TNF,IL-8, etc.Patients in CG will finish cardiopulmonary test.

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
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • according to GOLD, patients who are diagnosed as COPD, lung function at II or III grades (II:50%≤FEV1<60%pre;III:30%≤FEV1<50%pre);
  • 40≤age≤75 years old;
  • don't have acute exacerbation in the past one month;
  • SpO2 > 88% at rest;

排除标准

  • diabetes,blood glucose don't control well;
  • vascular diseases(vasculitis,deep venous thrombosis,varicose veins, etc);
  • joint diseases which may affect activities;
  • cerebrovascular diseases which may affect activities;
  • unstable angina during the past 1 month of acute myocardial infarction in the past 6 months;
  • severe arrhythmia;
  • cardia insufficiency;
  • hypertension which don't control well(systolic pressure>160mmHg and/or diastolic pressure> 100mmHg);
  • chronic liver or renal insufficiency;
  • cognitive handicap.

结局指标

主要结局

quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)

时间窗: two years

次要结局

未报告次要终点

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other

研究点 (1)

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