Trial document





This trial has been registered retrospectively.
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  DRKS00005979

Trial Description

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Title

The effect of wohole body vibration training therapy on patients with acute exacerbated COPD

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients with COPD suffer from periodic worsening of pre-existing symptoms (exacerbation). This causes hospitlizations. Standard physiotherapy consists of exercises in and around the bed and respiratory exercises. In this clinical trial patients are randomizid to either undergo standard physiotherapy or standard physiotherapy with the addition of whole body vibration (WBV). WBV is a new modality of physical exercise whereas the patients exercises on a vibrating platform. The goal of the study is to evaluate differences in the efficacy of these two training modalities during an exacerbation of COPD.

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Brief Summary in Scientific Language

Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by irreversible obstruction of the airways. The progression of the disease is associated with recurrent exacerbations that may lead to decline in lung function, quality of life and exercise capacity while increasing the risk for mortality. Cachexia and muscle atrophy are critical extra-pulmonary manifestations of COPD. It is well established that skeletal muscle function (strength and endurance) and structure (fiber quality, capillary density and metabolic capacity) are altered in patients with COPD i.e. shifted towards a decreased oxidative capacity of the muscle. In addition, it was shown that the anabolic-catabolic ratio is shifted towards the catabolic state of the muscle, which is accompanied by ischemia-related apoptosis injury.
Pulmonary rehabilitation improves exercise performance, dyspnea, and quality of life, reduces the effects of acute exacerbations and prolongs the interval between exacerbations. Current guidelines recommend pulmonary rehabilitation for all stages of COPD but do not explicitly recommend it during an acute exacerbation. The central components of rehabilitation are exercise and strength training. It is hypothesized that the expression of the transcription factor peroxisome-proliferator-activated receptor-γ coactivator 1α (PGC1-α) is relevant for the reconstitution of body strength by exercise training. PGC1-α stimulates expression of FNDC5, a membrane protein that is cleaved and secreted as a newly identified hormone called Irisin. The upregulation of PGC1-α has been shown to decrease inflammation and increase angiogenesis.
Whole body vibration (WBV) is a novel exercise training modality performed on a vibrating platform that moves in sinusoidal oscillations, during which static and dynamic exercises can be performed. A randomized clinical trial has demonstrated greater improvements in a number of exercise tests in the group of COPD patients (GOLD stages III and IV) trained on the WBV platform compared to a group that was conventionally trained.
We conducted a randomized clinical trial, in which we added WBV training to conventional physiotherapy in a group of patients hospitalised for a COPD exacerbation and compared this group to COPD subjects that only underwent conventional physiotherapy. The goal was to evaluate if WBV training is safe and improves exercise capacity and quality of life, and whether putative improvement is associated with measurable changes in circulating levels of irisin.

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Organizational Data

  •   DRKS00005979
  •   2014/03/17
  •   [---]*
  •   yes
  •   Approved
  •   197/10, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   J44.10 -  [generalization J44.1: Chronic obstructive pulmonary disease with acute exacerbation, unspecified]
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Interventions/Observational Groups

  •   Standard physiotherapy programme: 5 min mobilisation, 5 min passive movement, and 10 min respiratory exercises
  •   Standard programme complemented with sessions on the WBV device (Galileo™, Novotec Medical, Pforzheim, Germany). Additional training 3x2 min/day on the vibrating platform.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Difference of 6-MWT on admission and discharge

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Secondary Outcome

Quality of Live, Chair-Rising-Test, Muscle Sonography (Cross-sectional area), Inflammatory Markers, Markers of Muscle Activity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/03/09
  •   44
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with a documented exacerbation of a pre-existing COPD (GOLD 2 - 4) as defined in the national current guidelines ("Nationale Versorgungsleitlinie 2007": Worsening of pre-existing symptoms that resulted in the addition of antibiotics and/or corticosteroids) and written informed consent

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Exclusion Criteria

No COPD
Stable COPD
ACS (Elevation of TNI, CK, ECG abnormalities that may indicate myocardial infarction)

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Addresses

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    • Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Germany, Member of the German Center for Lung Research (DZL)
    • Mr.  PD Dr. med.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Germany, Member of the German Center for Lung Research (DZL)
    • Mr.  PD Dr. med.  Andreas Rembert  Kozculla 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Universitätsklinikum Giessen und Marburg Innere Medizin, Pneumologie
    • Ms.  Ursula  Boas 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Germany, Member of the German Center for Lung Research (DZL)
    • Mr.  PD Dr. med.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/07/23
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Trial Publications, Results and other Documents

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