Trial document




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  DRKS00007774

Trial Description

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Title

Effects of Whole Body Vibration Training on Balance and musclular efficiancy in patients with severe COPD

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Trial Acronym

Leonardo Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It has already been shown in an earlier study, that the whole-body Vibration (WBV) training in patients with severe COPD leads to a significant improvement in 6-minute walk distance. In the current study it should be investigated if these improvements are related to improvements in balance an muscular performance. Short- and long-term effects of WBV training will be measured by force measurement platform (Leonardo mechanography) which is able to analyse different physical parameters of Balance and muscle power. Measurements will be performed before and after the three weeks of Training (long-term effects), as well as directly before and after the training in the first three days (short-term effects) of the Galileo program.

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Brief Summary in Scientific Language

A former study by Gloeckl et al (2012) has shown a significant improvement in exercise capacity in patients with severe COPD. It should now be investigated if this benefits are caused by an increase in balance and muscular performance. COPD patients will be randomized completing a three week squat Training program either (1) during WBV training on the Galileo Vibration platform at high frequency (26Hz) or (2) on the floor in addition to conventional endurance and strength training. Balance and muscular power will be measured in the first three days of training right before and after Training (short-term effects). After completing the three week Training program Balance and muscluar Efficiency Parameters will be measured again (Long-term effects). These parameters will be analysed by a force measurement platform (Leonardo mechanography) using different assessement tests (Sit-to-Stand- Test, two leg jump, Balance Test).

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Organizational Data

  •   DRKS00007774
  •   2015/08/21
  •   2015/08/20
  •   yes
  •   Approved
  •   15006, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   U1111-1173-4557 
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Health Condition or Problem studied

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

  •   Patients in the intervention group will perform squat Training during whole body vibration training (three weeks in total: 3 times per week at 4x2xmin squats on the Galileo Vibration platform at 26Hz) in addition to their usual rehabilitation program (including conventional endurance and strength Training).
    Assessment on Balance and muscular power will be performed in the first three days of Rehabilitation (Pre- and post- training) (short-term effects) and after the 3-week Intervention (Long-term effects).
    The assessment of short-term effects will be performed in random order: squats on the Galileo, squats on the floor, resting (no squats).
  •   Patients in the control group will perform the same amount of squat training (three weeks in total: 3 times per week at 4x2xmin squats) but on the floor without whole Body Vibration. Also patients in the control Group will perform this in addition to their usual rehabilitation program (including conventional endurance and strength Training).
    Assessment on Balance and muscular power will be performed in the first three days of Rehabilitation (Pre- and post- training) (short-term effects) and after the 3-week Intervention (Long-term effects).
    The assessment of short-term effects will be performed in random order: squats on the Galileo, squats on the floor, resting (no squats).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Change in Balance between day 1 and 21 of Rehabilitation.
(Primary Outcome: "absolute path length" during 10 seconds of Standing in Tandem foot Position with eyes closed, measured by Leonardo mechanography force measurement platform)

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Secondary Outcome

- Sit- to stand- test (5-repetition sit-to-stand test, 1-minute sit-to-stand test); 6 min walk distance; isometric Peak muscular force for knee Extension and knee Flexion (measured by dynamometry; Quality of life (CRQ, PHQ questionnaires); all measurements will be performed on day 1 and 21 of pulmonary rehabilitation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/08/24
  •   74
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   80   Years
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Additional Inclusion Criteria

Patient referred to an pulmonary Rehabilitation program at the Schoen Klinik Berchtesgadener Land, approved diagnosis of COPD stage III or IV according to GOLD guidelines, written informed consent

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Exclusion Criteria

General medical reasons that do not allow physical exercise (e.g. acute coronary syndrom) or orthopedic comorbidities that do not permit squat training

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Addresses

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    • Schön Klinik Berchtesgadener Land
    • Mr.  Prof.  Klaus  Kenn 
    • Malterhöh 1
    • 83471  Schönau am Königssee
    • Germany
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    • Schön Klinik Berchtesgadener Land
    • Mr.  Dr.  Rainer  Glöckl 
    • Malterhöh 1
    • 83471  Schönau am Königssee
    • Germany
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    • Schön Klinik Berchtesgadener Land
    • Mr.  Dr.  Rainer  Glöckl 
    • Malterhöh 1
    • 83471  Schönau am Königssee
    • Germany
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Sources of Monetary or Material Support

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    • Schön Klinik Berchtesgadener Land
    • Mr.  Prof.  Klaus  Kenn 
    • Malterhoe 1
    • 83471  Schönau am Königssee
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/06/24
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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.