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临床试验/NCT00413543
NCT00413543终止不适用

Early Pulmonary Rehabilitation After Hospitalisation for Acute Exacerbation COPD

Isala2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2006年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Isala
入组人数
17
试验地点
2
主要终点
Exercise tolerance in meters

研究概览

简要总结

This is a study to evaluate the effects of early pulmonary rehabilitation within 10 days after discharge from the hospital after a COPD exacerbation on exercise tolerance, exacerbations, re-admissions and the quality of life during 6 months.

详细描述

Study Design:

One hundred patients with an acute exacerbation of COPD admitted to the regular pulmonology department via the emergency room will be recruited after they have given written informed consent. Inclusion criteria are an age > 40 years or ≤ 80 years, at least 10 pack years of smoking history and COPD at least GOLD II. Each form of physical therapy is accepted outside pulmonary rehabilitation. Exclusion criteria include participation in a pulmonary rehabilitation program in the preceding year, comorbidity that can limit exercise training (for example: invalidating ischaemic heart disease, RA, malignancy and lung embolus), intolerance to prednisone, history of asthma, non-compliance, findings on chest radiography other than fitting with signs of COPD and a prior randomisation. During admission patients will receive standard exacerbation COPD treatment consisting of O2, combivent inhalation, antibiotics and prednisone. Exercise capacity is measured by a 6 minute walk test performed at discharge. The COPD GOLD classification is detected with a spirometry after completion of exacerbation therapy and before randomisation and discharge.

Both measurements are repeated after completion of the pulmonary rehabilitation program at 3 months. Quality of life is evaluated by the following questionnaires at discharge: St. George respiratory questionnaire (SGRQ), SF-36-scores (short form health survey) and clinical COPD questionnaire (CCQ). Before discharge, patients are randomised with a computer minimisation program for pulmonary rehabilitation or usual care with special attendance to age (< 70 years or ≥ 70 years), sex, length of hospital stay (< 7 days or ≥ 7 days), six minute walk test distance at discharge (< 100 or ≥ 100 meters) and predicted forced expiratory volume in one second (FEV1< or ≥ FEV1). Pulmonary rehabilitation will take place within ten days after discharge and shall be given by a multidisciplinary team (pulmonologist, respiratory nurse, physical therapist, dietician and a social worker). The program will last 2 hours weekly; 1 hour exercise training and one hour education during 8 weeks. All patients are followed up after discharge at 3 and 6 months. These questionnaires will be repeated after accomplishment of the pulmonary rehabilitation program at day 90 and day 180. Readmission rate will be also evaluated in this period.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 40 years and < 80 years admitted to the hospital via ER
  • COPD at least Gold II
  • At least 10 pack years of smoking history
  • Physical therapy is tolerated, outside pulmonary rehabilitation

排除标准

  • Rehabilitation program < 1 year
  • Intolerance to prednisone
  • Non-compliance
  • Comorbidity limiting pulmonary rehabilitation
  • History of asthma
  • Prior randomisation
  • Findings on X thorax other than fitting with COPD

结局指标

主要结局

Exercise tolerance in meters

时间窗: 2 years

次要结局

  • Exacerbations, readmissions and quality of life during follow-up(2 years)

研究者

发起方
Isala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan W.K. van den Berg

pulmonologist

Isala

研究点 (2)

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