Trial document




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  DRKS00009759

Trial Description

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Title

Changes of spirometric data in the 6-MWT due to an outpatient PR in COPD patients: a controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to investigate the Impact of pulmonary Rehabilitation on the lung function. The control group won`t be part of the pulmonary rehabilitation.

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Brief Summary in Scientific Language

with this study we want to show the Impact of pulmonary Rehabilitation on the inspiratory capacity of COPD patients measured with the Spiropalm Cosmed Inc. while performing a 6 Minute Walking test pre and post a Rehabilitation programm

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Organizational Data

  •   DRKS00009759
  •   2015/12/10
  •   [---]*
  •   yes
  •   Approved
  •   135/2015, Ethikkomitee der Sporthochschule Köln
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Secondary IDs

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Health Condition or Problem studied

  •   chronic obstructive pulmonary disease
  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
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Interventions/Observational Groups

  •   COPD Patient stage II - IV take part at an outpatient rehabilitation Program at the Medical Clinic and the outpatient pulmonary Rehablilitation Center at Leverkusen (Training Group). At the beginning of the outpatient rehab program as well as at the end all participants perform a 6 - MWT while measuring spirometric parameters with Spiro Palm Cosmed Inc.
    The rehabilitation program lasts about 3 weeks, the patients exercise daily from 10 am - 4pm. The training contains special endurance and strength training.
  •   10 COPD patients stage II-IV served as a control Group while performing the same two 6-MWT within 3 weeks wearing the spiropalm without taking part at the rehab program.-
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

spirmetric mesasured inspiratory capacity, before and three weeks later, after the rehabilitation.

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Secondary Outcome

Maximum Minute volumne, breathing frequency, Walking distance in the 6 Minute Walking test, Oxygensaturation measured during the 6-MWT, usability questionere (7 Points lickert scale); before the rehabilitation program and three weeks later, at its end.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/12/01
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   90   Years
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Additional Inclusion Criteria

COPD stage II-IV in a stable condition, maximum 2 weeks to the last exacerbation, written consent, ability to walk

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Exclusion Criteria

Oxygen dependency, lost mobility, diagnosis making it impossible to complete the rehab program, no written consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • St. Remigius Krankenhaus
    • Mr.  Dr.  Marc  Spielmanns 
    • An St. Remigius 26
    • 51379  Leverkusen
    • Germany
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    • Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg, Klinik für Innere Medizin, Schwerpunkt Pneumologie
    • Mr.  Dr.  Tobias  Böselt 
    • Marburg
    • Germany
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    •   06421 58 638 35
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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
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Sources of Monetary or Material Support

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

  •   Recruiting ongoing
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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.