Trial document




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  DRKS00006070

Trial Description

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Title

Whole body vibration training in COPD patients during an outpatient exercise training program

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Trial Acronym

Galileo study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is uncertain if WBV is of any use according to an outpatient exercise training in COPD-pateints. Therefore we conducted a study with a 3 months lasting excercise training including WBV in comparison to conventionel training sessions.

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Brief Summary in Scientific Language

After randomisation COPD patients practicing squads using the whole body vibration (WBV) platform or parcticing squads alone (control group) during an outpatient exercise training program. The program last for 3 months. The target is to show whether the additioning WBV is safe and of any further benefit according to the primary outcome parameter.
The primary outcome parameter is the number of squads during the one minute sit-to-stand test (STS).

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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

  •   DRKS00006070
  •   2014/04/09
  •   [---]*
  •   yes
  •   Approved
  •   124/2013, Ethik-Kommission der Universität Witten/Herdecke
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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

  •   In cooperation with a professional local Training provider COPD patients having one or two exercise training sessions per week. In addition to the normal exercise training the Intervention group using the WBV while performing 3 times up to 20 squads. The training will be continued for 3 months. At least 12 training sessions should be completed. The sts (primary endpoint) and all the other parameters will be taken before starting and after 3 months.
  •   The control group is performing the same training and investigations except using the WBV.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The STS is conducted before starting the training sessins and after three months. The number of the squads during a one minute sit-to-stand test will be counted.

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Secondary Outcome

The walking distance during the 6 MWT and the CRQ-SAS Score will be conducted before starting the training and after 3 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2014/05/01
  •   50
  •   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

COPD stage II-IV
no exacerbations during the last 2 weeks
no limitations for regulary exercise training
ability and motivation for training at least once per week and absolvation of all needed investigations
written informed consent

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Exclusion Criteria

no written informed consent
comorbidity excluding regulary exercise training

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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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    • Krankenhaus BethanienKlinik für Pneumologie und Allergologie, Zentrum für Schlaf- und Beatmungsmedizin Direktor des wissenschaftlichen Instituts Bethanien
    • Mr.  Prof. Dr.  Winfried  Randerath 
    • Aufderhöher Str. 169-175 42699 Solingen
    • 42699 
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    •   0212 / 636001
    •   0212 / 63005
    •   [---]*
    •   [---]*
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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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    • 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 Leverkusen Opladen
    • An St. Remigius 26
    • 51379  Leverkusen
    • Germany
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    •   [---]*
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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.