Trial document



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  DRKS00006847

Trial Description

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Title

Effect of pneumological rehabilitation after an acute exacerbation of a COPD (chronic obstructiv pulmonal disease)

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Trial Acronym

REHAAECOPD

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URL of the Trial

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Brief Summary in Lay Language

With this study we would like to investigate if there is a positive effect of a pneumological rehabilitation after a acute exacerbation of a chronic pulmonal disease (COPD). An acute exacerbation means a worsening of an existing COPD going along with increasing distress, cough or sputum. These symptoms may occur alone or in combination. After a sufficient convalescence the test person are invited for taking part in the study. The classification of the proband in studygroup or controlgroup depends on whether a three weeks pneumological rehabilitation has been performed. Every test person will be invited again for further examination (Questionnaire, Lung-function test, 6-minutes walk control, Number of hospital stays in the time of one year after the exacerbation). After this there will be a comparison of the two study groups.

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Brief Summary in Scientific Language

Object of investigation are the long term effects of a pneumological rehabilitation program after an acute exacerbation of an existing COPD. Primary parameters are mortality, number of hospital stays (number of days) in the year after the exacerbation. Clinical parameters are lung function testing (FEV1), 6-minutes walk control, and questionnaire (CAT, SGRQ). 40 test persons are planned to be investigated in each group (study and control). In comparison may be shown an effect on the course of the disease. Also important is the economic aspect of the cost of an pneumological rehabilitation and if it reduces following costs in the health care system for instance by reducing the number of reexacerbations.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006847
  •   2015/05/12
  •   [---]*
  •   yes
  •   Approved
  •   101/2014, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   J44.99 -  [generalization J44.9: Chronic obstructive pulmonary disease, unspecified]
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Interventions/Observational Groups

  •   Three weeks pneumological rehabilitation after an acute exacerbation of an existing COPD (ambulant or stationary)
  •   Conventional therapy without rehabilitative procedure after AECOPD
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Mortality, number and duration of hospital stays in the following year after AECOPD

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Secondary Outcome

Questionnaire (CAT, SGRQ), Lung function parameter (FEV1), 6-minutes walk control (Reexamination >=1year after AECOPD)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/05/18
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Testing Persons with existing COPD in every stage. Hospitalisation because of an AECOPD. Probands must have the ability for rehabilitation and further examination. Agreement for examination and data acquisition. Age > 18 years.

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Exclusion Criteria

Rejection of data acquisition or examination. Lack of motivation. Age < 18years. Pregnancy and/or lactation. Alcohol- or drug abuse. Severe disease, which has a high risk of mortality in the following 12 months. Acute life-threatening condition. Every medical, psychological or any other condition, which leads to a limitation of a voluntary participation in the study.

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Addresses

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    • St Remigius Krankenhaus
    • Mr.  Dr.  Marc  Spielmanns 
    • An St Remigius 26
    • 51379  Leverkusen
    • Germany
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    • St Remigius Krankenhaus
    • Mr.  Dr.  Marc  Spielmanns 
    • An St Remigius 26
    • 51379  Leverkusen
    • Germany
    end of 1:1-Block address other
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    • St. Remigius Krankenhaus
    • Mr.  Benedikt  Meis 
    • An St. Remigius 26
    • 51379  Leverkusen
    • Germany
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    • Lungenklinik, Kliniken der Stadt Köln, MerheimLehrstuhl für Pneumologie der Universität Witten / Herdecke
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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  • start of 1:1-Block address public-contact
    • St Remigius Krankenhaus
    • Mr.  Dr.  Marc  Spielmanns 
    • An St Remigius 26
    • 51379  Leverkusen
    • Germany
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Sources of Monetary or Material Support

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    • Remigius Krankenhaus Leverkusen-Opladen
    • Mr.  Dr  Marc  Spielmanns 
    • An St Remigius 26
    • 51379  Leverkusen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.