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).
- 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.
- 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.
- 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.
- 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.
- 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
- 否
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
研究点 (1)
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