Trial document
DRKS00006847
Trial Description
Title
Effect of pneumological rehabilitation after an acute exacerbation of a COPD (chronic obstructiv pulmonal disease)
Trial Acronym
REHAAECOPD
URL of the Trial
[---]*
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.
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.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00006847
- 2015/05/12
- [---]*
- yes
- Approved
- 101/2014, Ethik-Kommission der Universität Witten/Herdecke
Secondary IDs
- [---]*
Health Condition or Problem studied
- J44.99 - [generalization J44.9: Chronic obstructive pulmonary disease, unspecified]
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
Characteristics
- Interventional
- [---]*
- Non-randomized controlled trial
- Open (masking not used)
- [---]*
- Active control
- Prevention
- Parallel
- N/A
- N/A
Primary Outcome
Mortality, number and duration of hospital stays in the following year after AECOPD
Secondary Outcome
Questionnaire (CAT, SGRQ), Lung function parameter (FEV1), 6-minutes walk control (Reexamination >=1year after AECOPD)
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Planned
- 2015/05/18
- 80
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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.
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.
Addresses
-
start of 1:1-Block address primary-sponsor
- St Remigius Krankenhaus
- Mr. Dr. Marc Spielmanns
- An St Remigius 26
- 51379 Leverkusen
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 021714092351
- 021714092359
- spielmanns at k-plus.de
- http://www.remigius.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- St Remigius Krankenhaus
- Mr. Dr. Marc Spielmanns
- An St Remigius 26
- 51379 Leverkusen
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 021714092351
- 021714092359
- spielmanns at k-plus.de
- http://www.remigius.de
end of 1:1-Block address contact other -
start of 1:1-Block address other
- St. Remigius Krankenhaus
- Mr. Benedikt Meis
- An St. Remigius 26
- 51379 Leverkusen
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 021714092655
- [---]*
- bmeis at k-plus.de
- http://www.remigius.de
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Lungenklinik, Kliniken der Stadt Köln, MerheimLehrstuhl für Pneumologie der Universität Witten / Herdecke
- Mr. Prof. Dr. Wolfram Windisch
- Ostmerheimer Str. 200
- 51109 Köln
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 221 8907 - 18929
- [---]*
- windischw at kliniken-koeln.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- St Remigius Krankenhaus
- Mr. Dr. Marc Spielmanns
- An St Remigius 26
- 51379 Leverkusen
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 021714092351
- [---]*
- spielmanns at k-plus.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Remigius Krankenhaus Leverkusen-Opladen
- Mr. Dr Marc Spielmanns
- An St Remigius 26
- 51379 Leverkusen
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 021714092351
- 021714092359
- spielmanns at k-plus.de
- http://www.remigius.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
- [---]*
Trial Publications, Results and other Documents
- [---]*