Trial document




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  DRKS00004338

Trial Description

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Title

Whole body vibration to preserve physical functioning in patients with hematological malignancies under chemotherapy

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Trial Acronym

ViTra-Pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Cancer patients suffer from therapy procedure, their underlining disease and from many side effects affecting their physical functioning. In addition long hospital stays limit their space for movement: during aplasia patients are not allowed to leave the ward and furthermore therapy induced side-effects lead to pronounced need to rest. These factors affect physical and psychological functioning. Previous studies could show that physical activity is a promising strategy to preserve physical functioning and improve quality of life. in this project the question will be answered if patients undergoing stationary chemotherapy are able to perform whole body vibration. From previous studies with elderly people is known that whole body vibration is as effective as moderate resistance training, that the sensorimotor system will be more strained and therefor results in a more functional benefit than standard resistance training. Furthermore the question shall be answered if whole body vibration can preserve mobility and improve postural control. Because most studies use endurance training as physical intervention, our primary outcome refers to the relation between performed and planed exercise sessions of the intervention group (whole body vibration) in contrast to the control group (endurance training).

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Brief Summary in Scientific Language

The aim of our pilot project is to investigate the eligibility of whole body vibration with cancer patients undergoing chemotherapy. For this reason we enclose patients with haematological malignancies with a planned hospitalisation of at least two weeks allocating them either to the IG (intervention group) or the CG (control intervention group). IG and CG will undergo an exercise regime for at least two weeks containing either a whole body vibration training (IG) or a moderate aerobic endurance training (CG) on three days/week. We choose endurance training as a control condition, because the eligibility is well known but there are only minimal effects on the neuromuscular system expected. The study design provides two assessment points: pre and post intervention. Eligibility of whole body vibration as our primary outcome will be measured by the numbers of training sessions carried out in relation to planned training sessions in comparison to CG. Further secondary endpoints are tolerability, postural control, mobility, muscle size and quality of life.

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Organizational Data

  •   DRKS00004338
  •   2012/11/30
  •   [---]*
  •   yes
  •   Approved
  •   267/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   hematologic malagnancies
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Interventions/Observational Groups

  •   Experimental intervention (intervention group): Wohle body vibration: 3x/ week on Galileo vibration plate
  •   Control intervention (control group): endurance training 3/week on a bicycle ergometer.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Performed exercise sessions in relation to planned exercise sessions of intervention group compared to control group [%], feasibility studxy

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Secondary Outcome

1. self created questionnaire about vibration tolerance [score]
2. Force plate (GKS 1000, Mittweida) [cm]
(sway path of center of pressure [COP]) and timed-up-and-go-test [sec] (postural control and mobility)
3. EORTC QLQ-C30 (quality of life questionnaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/04/03
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients with hematological malignancies and an planned stationary stay of at least two weeks because of chemotherapy, signed informed consent.

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Exclusion Criteria

Endoprosthesis in knee oder hip, other meta implant in lower extremities, fractures, acute arthritis, venous thrombosis, epilepsy, instable bone metastases, unknown back pain, acute slipped disc, myocardial infarction, Angina pectoris or heart disease (NYHA III-IV) in a time period of 6 months, arterial hypertension, cardial pacemaker, which is not treated adequately (in therapy >180mmHg systolic; >100mmHg diastolic),
Thrombocytes ≤ 10.000µl, hemoglobin < 8g/dl

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Addresses

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    • Universitätsklinik Freiburg,Klinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Prof. Dr.   Hartmut  Bertz 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    •   [---]*
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    • Universitätsklinik FreiburgKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Antonia  Pahl 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik FreiburgKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Antonia   Pahl 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Innere Medizin I Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Prof Dr  Hartmut  Bertz 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/31
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Trial Publications, Results and other Documents

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