Trial document




drksid header

  DRKS00000029

Trial Description

start of 1:1-Block title

Title

Exercise in severe COPD:
Is walking different to stair-climbing?

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

To asses physiological changes between walking and stair climbing in patients with severe COPD.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Sixteen COPD-patients (mean FEV1 33±13 %predicted) underwent a six-minute walking test and performed stair-climbing (44 steps) in a randomized cross-over design. Blood gases, blood lactate, lung function parameters, maximal inspiratory mouth, sniff nasal and twitch mouth pressures, blood pressure, heart rate, and Borg Dyspnea Scale (BDS) were measured before and after exercise.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000029
  •   2008/09/05
  •   2007/10/31
  •   no
  •   Approved
  •   098/06, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   UKF001282  (Register Klinischer Studien des Universitätsklinikums Freiburg)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J44 -  Other chronic obstructive pulmonary disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   assessment of physiological changes after 6 minutes walking and after 44 stair climbing in patients with severe COPD
  •   assessment of physiological changes after 44 stair climbing and after 6 minutes walking in patients with severe COPD
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   [---]*
  •   Crossover
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Difference in the change of PaO2 when comparing walking and stair-climbing

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Blood gases, blood lactate, lung function parameters, maximal inspiratory mouth, sniff nasal and twitch mouth pressures, blood pressure, heart rate, and Borg Dyspnea Scale (BDS)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2006/07/01
  •   16
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Stable stage III and IV COPD patients according to GOLD criteria13 were included.
Only patients who reported dyspnea already during mildest exertion were studied. Furthermore, all patients stated that their exercise capacity was limited by dyspnea and not by skeletal muscle weakness.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

[---]*

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg Innere Medizin - Pneumologie
    • Mr.  Dr. med.  Michael  Dreher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg Innere Medizin - Pneumologie
    • Mr.  Dr. med.  Michael  Dreher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • [---]*
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2007/03/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   http://www.ncbi.nlm.nih.gov/pubmed/18280129?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.