Trial document





This trial has been registered retrospectively.
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  DRKS00006077

Trial Description

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Title

Effects of long-term outpatient exercise training in moderate to severe non-hypoxemic COPD patients with or without oxygen supply during the training session

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We performed a 24 weeks structured training program with progressively increasing loads. In addition, we compared the influences of oxygen supplementation.

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Brief Summary in Scientific Language

36 moderate to severe COPD patients trained supervised over 24 weeks 3 times per week and 30 minutes per session. During training, one group received oxygen-supply via nasal cannulas with a flow of 4 L x min-1, the other group got compressed air with the same flow. Lung function tests at rest (IVC, FEV1, Tiffaneau-Index) cycle-spiroergometry (peak ventilation, peak oxygen uptake, peak RER, submaximal and peak lactic acid concentrations), 6 minute walk testing and quality of life (SF 36) were conducted before, after 12 weeks, and after 24 weeks of training.

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Organizational Data

  •   DRKS00006077
  •   2014/04/11
  •   [---]*
  •   yes
  •   Approved
  •   keine Nummer, Ethics Committee of the Sports University Cologne, Germany.
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

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

  •   Identical to the training period, one group was supplied with 4 L x min-1 oxygen via nasal cannulas (oxygen group) (training over 24 weeks 3 times per week and 30 minutes per session)
  •   The other group got compressed air with the same flow via nasal cannulas (air group) (training over 24 weeks 3 times per week and 30 minutes per session).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The difference of the distance achieved in the 6 minute walk test constituted the primary outcome measure, measured before the training, at midtime (after 12 weeks) and at the end of the training sessions (after 24 weeks).

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Secondary Outcome

The maximum work load and the maximum oxygen uptake measured with the ergospirometry and changes at the SF36 assessment test (quality of life), each taken at the beginning, at midtime (after 12 weeks) and at the end (after 24 weeks) were the secondary outcomes.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2009/09/17
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Only patients with the diagnosis of COPD, and FEV1/FVC-ratio <0.7 after bronchodilatation and forced expiratory volume in 1 s (FEV1) <80% of predicted value were included. Stable clinical condition for at least 4 weeks and normoxemia at rest and during exercise were necessary. Until the entry in the study they should not performed regular physical training.

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Exclusion Criteria

Exclusion criteria were other diseases that could interfere with training (e.g. ischemic cardiac disease, musculo-skeletal problems) and psychological disorders.A criterion for fulfilling the training was participation of at least 80% of the sessions.

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Addresses

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    • Remigius-Krankenhaus Leverkusen – OpladenMedizinische Klinik und ambulante pneumologische Rehabilitation
    • Mr.  Dr.  Marc  Spielmanns 
    • An St. Remigius 26
    • 51581  Leverkusen
    • Germany
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    • Trainingsinstitut Prof. Baum
    • Mr.  Prof. Dr.  Klaus  Baum 
    • Wilhelm Schlombs Allee 1
    • 50858  Köln
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Remigius-Krankenhaus Leverkusen – OpladenMedizinische Klinik und ambulante pneumologische Rehabilitation
    • Mr.  Dr.  Marc  Spielmanns 
    • An St. Remigius 26
    • 51581  Leverkusen
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Remigius-Krankenhaus Leverkusen – OpladenMedizinische Klinik und ambulante pneumologische Rehabilitation
    • Mr.  Dr.  Marc  Spielmanns 
    • An St. Remigius 26
    • 51581  Leverkusen
    • Germany
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Sources of Monetary or Material Support

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    • St. Remigius Krankenhaus Leverkusen-Opladen
    • An St. Remigius 26
    • 51379  Leverkusen
    • Germany
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    •   021714090
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/02/14
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Trial Publications, Results and other Documents

  •   Marc Spielmanns, Chantal Fuchs-Bergsma, Aurelia Winkler, Gabriele Fox, Stefan Krüger, Klaus Baum, Effects of Oxygen Supply During Training on Subjects With COPD Who Are Normoxemic at Rest and During Exercise: A Blinded Randomized Controlled Trial Respir Care, April 2015 60:4 540-548; published ahead of print December 16, 2014, doi:10.4187/respcare.03647
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* This entry means the parameter is not applicable or has not been set.